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Roxee Meds Catalog

Ketamine Hydrochloride

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Liquid (Solution) Multiple FDA sponsors Official label facts Owner quick guide first
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Data freshness

Storefront facts
Catalog refreshed
Apr 22, 2026, 10:07 a.m.

These are the storefront facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 15, 2026

Updated: April 15, 2026, 10:04 AM UTC

Sources:
Image coming soon
Ketamine Hydrochloride

Ketamine Hydrochloride

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Liquid (Solution) Rx required 100% storefront ready

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Ketamine Hydrochloride

It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation. It is used for restraint. It is used in cats as the sole anesthetic agent for ovariohysterectomy and general surgery. Species commonly shown: Both, Cat, No Use Class Stated Or Implied, Primates, Non-Human Primates.

Generic name
Ketamine Hydrochloride
Brand names
Ketamine Hydrochloride Injection, Ketamine Hydrochloride Injection, USP, VetaKet®, Ketamine HCL
Manufacturer
Multiple FDA sponsors
Species
Both, Cat, No Use Class Stated Or Implied, Primates, Non-Human Primates, Cat, Restricted During Pregnancy
Dosage forms
Liquid (Solution)
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Ketamine Hydrochloride Injection Ketamine Hydrochloride Injection, USP VetaKet® Ketamine HCL KetaFlo™
Dosage forms
Liquid (Solution)

Indications / Uses

It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation. It is used for restraint. It is used in cats as the sole anesthetic agent for ovariohysterectomy and general surgery.

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Seizure NOS, INEFFECTIVE, ANESTHESIA, Death, Cardiac arrest, Drug administration error, Vomiting.

FAQ

Both, Cat, No Use Class Stated Or Implied, Primates, Non-Human Primates, Cat, Restricted During Pregnancy

Yes. Roxee shows this as prescription-only.

Liquid (Solution)

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

It is used for restraint.

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Store in a cool place
  • Protect from light
  • Do not use if precipitate appears
  • Loss of appetite (1 reports)
  • Elevated aspartate aminotransferase (1 reports)
  • Dry mucous membrane (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
Major cautions & emergency warning signs

Side effects to monitor:

  • Store in a cool place
  • Protect from light
  • Do not use if precipitate appears
  • Loss of appetite
  • Elevated aspartate aminotransferase

Most reported reactions:

  • Loss of appetite (1 reports)
  • Elevated aspartate aminotransferase (1 reports)
  • Dry mucous membrane (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA sponsors
Form: Liquid (Solution)
Identifiers:
ANADA: 200029 ANADA: 200042 ANADA: 200055 ANADA: 200073 ANADA: 200257 ANADA: 200279 NADA: 45290 NADA: 92116 NDC Package: 11695-0703-1 NDC Package: 11695-7039-1 NDC Package: 13985-584-10 NDC Package: 17033-101-10 NDC Package: 54771-2013-1 NDC Package: 69043-063-01 NDC Package: 86136-144-31 NDC Product: 11695 NDC Product: 13985 NDC Product: 17033 NDC Product: 54771 NDC Product: 69043
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
22
Species represented
2
Grouped by Body System
Digestive (4) · Loss of appetite, Diarrhea, Decreased appetite Skin & allergy (1) · Hair loss at application site Neurologic (1) · Depression Behavior (3) · Biting -aggression, Behavioral disorder (unspecified), Anxiety Other (23) · Elevated aspartate aminotransferase, Elevated alanine aminotransferase, Dysphoria
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Digestive 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Digestive 1 Cat 1

Species coverage: Cat (23) Dog (9)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Cat Serious - 1
Skin & allergy Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Digestive Dog Serious - 1
Other Cat Serious - 1
Neurologic Cat Non-serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Digestive Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Digestive Cat Serious - 1
Other Dog Serious - 1
Behavior Dog Serious - 1
Other Dog Serious - 1
Behavior Cat Non-serious - 1
Other Dog Non-serious - 1
Behavior Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Source metadata:

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

6

FOI

6

Ketamine HCL

SPL · SPL

Open original
FDA Structured Product Label

Ketamine HCL

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Mylan Institutional LLC, a Viatris Company
ANADA
200-257
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
Primates, Non-Human Primates • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.

Subhuman primates

Indication
It is used for restraint.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 3 to 15 milligrams per kilogram of body weight depending upon the species, general condition and age of the subject.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

VetaKet®

SPL · SPL

Open original
FDA Structured Product Label

VetaKet®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-055
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
Primates, Non-Human Primates • Cat, Restricted During Pregnancy
Composition / specifications
The drug is a sterile aqueous solution and each milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.

Cats

Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears.

Subhuman primates

Indication
It is used for restraint.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 3 to 15 milligrams per kilogram of body weight depending upon the species, general condition and age of the subject.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears.

Ketamine Hydrochloride Injection

SPL · SPL

Open original
FDA Structured Product Label

Ketamine Hydrochloride Injection

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-029
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
Cat, No Use Class Stated Or Implied
Composition / specifications
The drug is a sterile aqueous solution and each milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.

Cats

Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears.

Ketamine Hydrochloride Injection, USP

SPL · SPL

Open original
FDA Structured Product Label

Ketamine Hydrochloride Injection, USP

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
ANADA
200-042
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
Primates, Non-Human Primates • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.

Subhuman primates

Indication
It is used for restraint.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 3 to 15 milligrams per kilogram of body weight depending upon the species, general condition and age of the subject.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Ketamine Hydrochloride Injection, USP

SPL · SPL

Open original
FDA Structured Product Label

Ketamine Hydrochloride Injection, USP

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Dechra Veterinary Products LLC
ANADA
200-073
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
Primates, Non-Human Primates • Cat, No Use Class Stated Or Implied
Composition / specifications
The drug is a sterile aqueous solution and each milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.

Cats

Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears.

Subhuman primates

Indication
It is used for restraint.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 3 to 15 milligrams per kilogram of body weight depending upon the species, general condition and age of the subject.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears.

KetaFlo™

SPL · SPL

Open original
FDA Structured Product Label

KetaFlo™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Abbott Laboratories
ANADA
200-279
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
Primates, Non-Human Primates • Cat, No Use Class Stated Or Implied
Composition / specifications
The drug is a sterile aqueous solution and each milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.

Cats

Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Subhuman primates

Indication
It is used for restraint.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 3 to 15 milligrams per kilogram of body weight depending upon the species, general condition and age of the subject.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

ucm061682.pdf

FOI · FOI

Open original

A200055_Orig_08_03_1998.pdf

FOI · FOI

Open original

A200029_Org_8_16_1995.pdf

FOI · FOI

Open original

A200042_Orig_06_30_1994.pdf

FOI · FOI

Open original

A200073_Org_7_21_1994.pdf

FOI · FOI

Open original

ucm061704.pdf

FOI · FOI

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Storefront facts: Source Roxee | Refreshed Apr 22, 2026, 10:07 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Primates
Rx/OTC: RX
Form/route: Liquid (Solution) • Intramuscular
Applications: ANADA 200-257 • ANADA 200-055 • ANADA 200-029 • ANADA 200-042 • ANADA 200-073 • ANADA 200-279
Documents: 6 (FOI: 6) • SPL: 6 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 31 • Cat 54 • View
Case summaries: 25 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Loss of appetite (1) Elevated aspartate aminotransferase (1) Dry mucous membrane (1) Diarrhea (1) Dermatosis NOS (1) Dehydration (1) Decreased haematocrit (1) Decreased appetite (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200029 ANADA: 200042 ANADA: 200055 ANADA: 200073 ANADA: 200257 ANADA: 200279 NADA: 45290 NADA: 92116 NDC Package: 11695-0703-1 NDC Package: 11695-7039-1 NDC Package: 13985-584-10 NDC Package: 17033-101-10 NDC Package: 54771-2013-1 NDC Package: 69043-063-01 NDC Package: 86136-144-31 NDC Product: 11695 NDC Product: 13985 NDC Product: 17033 NDC Product: 54771 NDC Product: 69043 NDC Product: 86136
Package NDC Product NDC Form / Route Status
11695-0703-1 11695 -
11695-7039-1 11695 -
13985-584-10 13985 -
17033-101-10 17033 -
54771-2013-1 54771 -
69043-063-01 69043 -
86136-144-31 86136 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 16 Clinical 9 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appe… (Clinical, 2026-04-15)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appe… (Clinical, 2026-04-15)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appe… (Clinical, 2026-04-11)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Seizure NOS, INEFFECTIVE, ANESTHESIA, Death, Cardiac arrest, Drug administration error, Vomiting. (Clinical, 2026-04-11)
  • usage: It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation. It i… (Clinical, 2026-04-15)
  • usage: It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation. It i… (Clinical, 2026-04-15)
  • usage: It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation. It i… (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appe… (Official, 2026-04-22)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appe… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Seizure NOS, INEFFECTIVE, ANESTHESIA, Death, Cardiac arrest, Drug administration error, Vomiting. (Official, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Seizure NOS, INEFFECTIVE, ANESTHESIA, Death, Cardiac arrest, Drug administration error, Vomiting. (Official, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Seizure NOS, INEFFECTIVE, ANESTHESIA, Death, Cardiac arrest, Drug administration error, Vomiting. (Official, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Seizure NOS, INEFFECTIVE, ANESTHESIA, Death, Cardiac arrest, Drug administration error, Vomiting. (Official, 2026-02-12)
  • usage: It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation. It i… (Official, 2026-04-22)
  • usage: Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. (Official, 2026-04-16)
  • usage: Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. (Official, 2026-04-15)
  • usage: It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation. It i… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-16 13:28 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-16 13:27 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-16 13:27 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-16 13:27 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-16 13:27 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-16 13:27 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:06 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:06 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:06 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-15 10:06 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-15 10:06 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-15 10:06 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-15 10:06 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-15 10:06 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-15 10:06 by curated_loader • Official FDA application reference for Senvelgo.
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Ketamine HCL
RX
Ketamine Hydrochloride
Liquid (Solution) • Intramuscular
Label highlights
Official documents
Mylan Institutional LLC, a Viatris Company ANADA 200-257 W Jan 21, 2025
VetaKet®
RX
Ketamine Hydrochloride
Liquid (Solution) • Intramuscular
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-055 Approved Jun 13, 2024
Ketamine Hydrochloride Injection
RX
Ketamine Hydrochloride
Liquid (Solution) • Intramuscular
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-029 Approved Feb 1, 2018
Ketamine Hydrochloride Injection, USP
RX
Ketamine Hydrochloride
Liquid (Solution) • Intramuscular
Label highlights
Official documents
Elanco US Inc. ANADA 200-042 Approved Aug 4, 2017
Ketamine Hydrochloride Injection, USP
RX
Ketamine Hydrochloride
Liquid (Solution) • Intramuscular
Label highlights
Official documents
Dechra Veterinary Products LLC ANADA 200-073 Approved May 19, 2017
KetaFlo™
RX
Ketamine Hydrochloride
Liquid (Solution) • Intramuscular
Label highlights
Official documents
Abbott Laboratories ANADA 200-279 W Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Primates, Non-Human Primates • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.
Subhuman primates
Indication
It is used for restraint.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 3 to 15 milligrams per kilogram of body weight depending upon the species, general condition and age of the subject.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cats
Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Primates, Non-Human Primates • Cat, Restricted During Pregnancy
Composition / specifications
The drug is a sterile aqueous solution and each milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.
Cats
Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears.
Subhuman primates
Indication
It is used for restraint.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 3 to 15 milligrams per kilogram of body weight depending upon the species, general condition and age of the subject.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears.

FDA page: Open in Animal Drugs @ FDA

Species: Cat, No Use Class Stated Or Implied
Composition / specifications
The drug is a sterile aqueous solution and each milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.
Cats
Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears.

FDA page: Open in Animal Drugs @ FDA

Species: Primates, Non-Human Primates • Cat, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.
Subhuman primates
Indication
It is used for restraint.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 3 to 15 milligrams per kilogram of body weight depending upon the species, general condition and age of the subject.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cats
Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Primates, Non-Human Primates • Cat, No Use Class Stated Or Implied
Composition / specifications
The drug is a sterile aqueous solution and each milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.
Cats
Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears.
Subhuman primates
Indication
It is used for restraint.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 3 to 15 milligrams per kilogram of body weight depending upon the species, general condition and age of the subject.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears.

FDA page: Open in Animal Drugs @ FDA

Species: Primates, Non-Human Primates • Cat, No Use Class Stated Or Implied
Composition / specifications
The drug is a sterile aqueous solution and each milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams ketamine base activity.
Cats
Indication
It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 5 to 15 milligrams per pound of body weight depending on the effect desired.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Subhuman primates
Indication
It is used for restraint.
Dosage
It is administered intramuscularly at a recommended dose that ranges from 3 to 15 milligrams per kilogram of body weight depending upon the species, general condition and age of the subject.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

It is used for restraint or as the sole anesthetic agent in diagnostic or minor, brief surgical procedures that do not require skeletal muscle relaxation. It is used for restraint. It is used in cats as the sole anesthetic agent for ovariohysterectomy and general surgery.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Store in a cool place. Protect from light. Do not use if precipitate appears. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Cat Diarrhea (1) • Dog Decreased appetite (1) • Cat Bloody diarrhoea (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Hair loss at application site (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Depression (1) • Cat

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Dog Behavioral disorder (1) • Cat Anxiety (1) • Dog

Showing top 5 for Behavior.

Other
Elevated aspartate aminotransferase (1) • Dog Elevated alanine aminotransferase (1) • Cat Dysphoria (1) • Cat Dry mucous membrane (1) • Cat Dermatosis NOS (1) • Cat
Show more (18)
Dehydration (1) • Cat Decreased pulse oxygenation (1) • Cat Decreased haematocrit (1) • Cat Decreased body temperature (1) • Cat Death (1) • Dog Cardiorespiratory arrest (1) • Cat Cardiac disorder NOS (1) • Cat Cardiac arrest (1) • Cat Breathing difficulty (1) • Cat Blood loss NOS (1) • Dog Bilirubinuria (1) • Dog Application site scar (1) • Dog Anaemia NOS (1) • Cat Agitation (1) • Cat Adipsia (1) • Cat Abnormal radiograph finding (1) • Cat Abnormal posture NOS (1) • Dog Abdominal effusion (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Greyhound, Female, 9 year, 27.3 kilogram • Drug: MSK, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-075461
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 9.00 Year
  • Weight: 27.300 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
Reactions Reported:
Lack of efficacy - NOS Unrelated death
Outcomes: Euthanized

Dog, ['Retriever - Golden', 'Poodle - Standard'], Male, 5 year, 25.5 kilogram • Drug: MSK, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-075440
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 25.500 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
Reactions Reported:
Lack of efficacy - NOS Unrelated death
Outcomes: Euthanized

Dog, Crossbred Canine/dog, Male, 14 year, 17.7 kilogram • Drug: MSK, Subcutaneous • Reactions: Lack of efficacy - NOS, Unrelated death • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-075367
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 17.700 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
Reactions Reported:
Lack of efficacy - NOS Unrelated death
Outcomes: Euthanized

Cat, Domestic Shorthair, Female, 6 month, 3.084 kilogram • Drug: MSK, Unknown, Dose: 0.70 Milligram per animal • Reactions: Elevated temperature, Breathing difficulty, Quiet • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074179
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 6.00 Month
  • Weight: 3.084 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 0.70 Milligram per animal
Reactions Reported:
Elevated temperature Breathing difficulty Quiet
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 4 month, 2.5 kilogram • Drug: MSK, Injection, solution, Unknown • Reactions: Drooling, Tachypnoea, Abnormal radiograph finding, Hypothermia, Hyperactivity… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074533
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 4.00 Month
  • Weight: 2.500 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Injection, solution
Reactions Reported:
Drooling Tachypnoea Abnormal radiograph finding Hypothermia Hyperactivity Not eating Tiredness (lethargy) Hiding
Outcomes: Ongoing

Dog, Coton de Tuléar, Female, 4 year, 3.719 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Lack of efficacy - NOS, Vomiting, Intentional misuse • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074366
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.00 Year
  • Weight: 3.719 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Lack of efficacy - NOS Vomiting Intentional misuse
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 5 month, 3.62 kilogram • Drug: MSK, Intravenous • Reactions: Seizure NOS, Agitation • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-073634
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Month
  • Weight: 3.620 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
Reactions Reported:
Seizure NOS Agitation
Outcomes: Outcome Unknown

Dog, ['Retriever - Golden', 'Poodle - Standard'], Male, 7 year, 43.273 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Thrombocytopenia, Blood loss NOS, Skin petechiae, Death • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-074431
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 43.273 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Thrombocytopenia Blood loss NOS Skin petechiae Death
Outcomes: Died

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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