Skip to main content
Start triage

Start triage first, then route to emergency care.

Start symptom intake Emergency vets near you

Need urgent help? Start triage first, then route to emergency care.

Start symptom intake Emergency vets near you

Roxee Medication Guide

Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Chewable Tablets Boehringer Ingelheim Animal Health USA Inc. Official label facts Owner quick guide first
Start Symptom Intake Talk to a Vet / Find a Vet Near You

Veterinary professional?

Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

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

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

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

Safety reports
No safety reports linked
No refresh timestamp yet

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

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Image coming soon
Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet

Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Chewable Tablets Rx required 100% reference complete

Species: Both

Manufacturer: Boehringer Ingelheim Animal Health USA Inc.

Medication Snapshot

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

Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala ) and roundworm ( Toxocara canis and Toxascaris leonina ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (blacklegged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (longhorned tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. Species commonly shown: Both, Dog.

Generic name
Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet
Brand names
NexGard® PLUS, NexGard PLUS
Manufacturer
Boehringer Ingelheim Animal Health USA Inc.
Species
Both, Dog
Dosage forms
Chewable Tablets
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
NexGard® PLUS NexGard PLUS
Dosage forms
Chewable Tablets

Indications / Uses

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ) and roundworm ( Toxocara canis and Toxascaris leonina ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (blacklegged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (longhorned tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Side Effects

Top reported reactions (openFDA): Vomiting, Diarrhoea, Lack of efficacy (endoparasite) - hookworm, Lethargy (see also Central nervous system depression in Neurological), Lack of efficacy (endoparasite) - roundworm NOS, Lack of efficacy (bacteria) - Borrelia.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Chewable Tablets

Related Conditions

Fleas (Flea Infestation) Heartworm Disease

Source Transparency

Add to My Pet's Medications

Choose a pet, confirm current or past, and optionally add reminder notes.

Sign in to save this medication to your pet profile.

Sign in to continue

Pet Owner Quick Guide

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

Used for:

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ) and roundworm ( Tox...

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:

  • Seizure NOS (1 reports)
  • Death (1 reports)
  • Anaemia NOS (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.

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?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2023-US-058777
Safety signal coverage Reported signals

15 tracked reaction signals; 13 reported cases; 3 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2023-US-058777
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2023-US-058777
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Seizure NOS (1 reports), Death (1 reports), Anaemia NOS (1 reports), Vomiting (1 reports), Tiredness (lethargy) (1 reports)

Body systems represented Signal grouping

Digestive (3), Neurologic (2), Effectiveness (4), Other (6)

Species and breed lens

Species represented in reports Species lens

Dog (13 reports), Cat (2 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Seizure NOS, Death, Anaemia NOS

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Afoxolaner 37.5Mg / Moxidectin 180Mcg / Pyrantel 75Mg Chewable Tablet brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2023-US-058777 · adverse_reaction · adverse reactions
  2. FDA application profile · official_label · quick facts
  3. Medication usage source · fda_animal_drugs · quick facts
  4. FOI · document · documents
  5. FOI · document · documents
  6. FOI · document · documents
  7. FOI · document · documents
  8. SPL · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 22, 2026, 10:06 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Seizure NOS
  • Death
  • Anaemia NOS

Most reported reactions:

  • Seizure NOS (1 reports)
  • Death (1 reports)
  • Anaemia NOS (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

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / use
For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum , Ancylostoma braziliense , and Unc…
Form / route / dose
Form: Chewable Tablets
Route: Oral
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Boehringer Ingelheim Animal Health USA Inc.
Form: Chewable Tablets
Identifiers:
NADA: 141554 NDC Package: 0010-4260-01 NDC Package: 0010-4260-02 NDC Package: 0010-4260-03 NDC Package: 0010-4261-01 NDC Package: 0010-4261-02 NDC Package: 0010-4261-03 NDC Package: 0010-4262-01 NDC Package: 0010-4262-02 NDC Package: 0010-4262-03 NDC Package: 0010-4263-01 NDC Package: 0010-4263-02 NDC Package: 0010-4263-03 NDC Package: 0010-4264-01 NDC Package: 0010-4264-02 NDC Package: 0010-4264-03 NDC Product: 0010
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
15
Reported cases
13
Serious reports
3
Species represented
2
Grouped by Body System
Digestive (3) · Vomiting, Diarrhea, Bloody diarrhoea Neurologic (2) · Tiredness (lethargy), Seizure NOS Effectiveness (4) · Lack of efficacy (endoparasite) - tapeworm, Lack of efficacy (endoparasite) - roundworm NOS, Lack of efficacy (endoparasite) - hookworm Other (6) · Not eating, Death, Anaemia NOS
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Digestive 1 Cat 0
Neurologic 1 Dog 0
Other 1 Dog 0
Effectiveness 1 Dog 0
Effectiveness 1 Dog 0

Species coverage: Dog (13) Cat (2)

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

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

NexGard® PLUS SPL · SPL NexGard PLUS SPL SPL · Structured Product Label FOI Summary sN 141-554 Approved January 20, 2026.pdf FOI · FOI

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

2

FOI

4

NexGard® PLUS

SPL · SPL

Open original
FDA Structured Product Label

NexGard® PLUS

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

Sponsor
Boehringer Ingelheim Animal Health USA, Inc.
NADA
141-554
Status
RX
Form
Chewable Tablets
Route
Oral
Species
Dog
Composition / specifications
Each chewable tablet contains 9.375 mg afoxolaner, 45 mcg moxidectin, and 18.75 mg pyrantel; 18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel; 37.5 mg afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel; 75 mg afoxolaner, 360 mcg moxidectin, and 150 mg pyrantel; or 150 mg afoxolaner, 720 mcg moxidectin, and 300 mg pyrantel.

Dogs

Indication

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris leonina) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (blacklegged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (longhorned tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Dosage

Administer orally once a month at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel (as pamoate salt). For heartworm disease prevention, give once monthly for at least six months after last exposure to mosquitoes.

NexGard PLUS SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for NexGard PLUS. Use the source link for the full official labeling record.

FOI Summary sN 141-554 Approved January 20, 2026.pdf

FOI · FOI

Open original

FOI Summary sN 141-554 Approved April 23 2025_EF.pdf

FOI · FOI

Open original

FOI Summary sN 141-554 Approved October 7, 2024.pdf

FOI · FOI

Open original

FOI Summary oN 141-554 Approved July 19, 2023.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
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: NexGard PLUS
Manufacturer mapping: Boehringer Ingelheim Animal Health USA Inc.
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Chewable Tablets • Oral
Applications: NADA 141-554
NDC: Packages 0010-4260-01 0010-4260-02 0010-4260-03 0010-4261-01 0010-4261-02 0010-4261-03 • Products 0010
Documents: 4 (FOI: 4) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: B74.8 ICD10_CM: B88.1
Other filariases

Counseling and Monitoring Highlights

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

Top reaction signals
Seizure NOS (1) Death (1) Anaemia NOS (1) Vomiting (1) Tiredness (lethargy) (1) Not eating (1) Lack of efficacy (endoparasite) - tapeworm (1) Lack of efficacy (endoparasite) - roundworm NOS (1)

Identifiers & Packages

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

Identifiers
NADA: 141554 NDC Package: 0010-4260-01 NDC Package: 0010-4260-02 NDC Package: 0010-4260-03 NDC Package: 0010-4261-01 NDC Package: 0010-4261-02 NDC Package: 0010-4261-03 NDC Package: 0010-4262-01 NDC Package: 0010-4262-02 NDC Package: 0010-4262-03 NDC Package: 0010-4263-01 NDC Package: 0010-4263-02 NDC Package: 0010-4263-03 NDC Package: 0010-4264-01 NDC Package: 0010-4264-02 NDC Package: 0010-4264-03 NDC Product: 0010
Package NDC Product NDC Form / Route Status
0010-4260-01 0010 -
0010-4260-02 0010 -
0010-4260-03 0010 -
0010-4261-01 0010 -
0010-4261-02 0010 -
0010-4261-03 0010 -
0010-4262-01 0010 -
0010-4262-02 0010 -
0010-4262-03 0010 -
0010-4263-01 0010 -
0010-4263-02 0010 -
0010-4263-03 0010 -
0010-4264-01 0010 -
0010-4264-02 0010 -
0010-4264-03 0010 -

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 121 Clinical 4 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Vomiting, Diarrhoea, Lack of efficacy (endoparasite) - hookworm, Lethargy (see also Central nervous system depression in Neur… (Clinical, 2026-05-02)
  • side_effects: Top reported reactions (openFDA): Vomiting, Diarrhoea, Lack of efficacy (endoparasite) - hookworm, Lethargy (see also Central nervous system depression in Neur… (Clinical, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Vomiting, Diarrhoea, Lack of efficacy (endoparasite) - hookworm, Lethargy (see also Central nervous system depression in Neur… (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Vomiting, Diarrhoea, Lack of efficacy (endoparasite) - hookworm, Lethargy (see also Central nervous system depression in Neur… (Clinical, 2026-04-11)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-22)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-22)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-21)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-20)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-13)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-12)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-12)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-11)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-11)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-10)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-09)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-08)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-07)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-06)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-05)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma bra… (Official, 2026-06-04)
Recent Revisions
  • side_effects updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects 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
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 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
NexGard® PLUS
RX
Afoxolaner Moxidectin Pyrantel Pamoate
Chewable Tablets • Oral
Label highlights
Official documents
Boehringer Ingelheim Animal Health USA, Inc. NADA 141-554 Approved Feb 2, 2026

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: Dog
Composition / specifications
Each chewable tablet contains 9.375 mg afoxolaner, 45 mcg moxidectin, and 18.75 mg pyrantel; 18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel; 37.5 mg afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel; 75 mg afoxolaner, 360 mcg moxidectin, and 150 mg pyrantel; or 150 mg afoxolaner, 720 mcg moxidectin, and 300 mg pyrantel.
Dogs
Indication

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) and roundworm (Toxocara canis and Toxascaris leonina) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (blacklegged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (longhorned tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Dosage

Administer orally once a month at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel (as pamoate salt). For heartworm disease prevention, give once monthly for at least six months after last exposure to mosquitoes.

Limitations

FDA page: Open in Animal Drugs @ FDA

Usage

For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ) and roundworm ( Toxocara canis and Toxascaris leonina ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (blacklegged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), and Haemaphysalis longicornis (longhorned tick) infestations for one month in dogs and puppies eight weeks of age and older, weighing four pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Source: FDA Animal Drugs @ FDA • Reference

Top Reported Reactions (openFDA)

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

Digestive
Vomiting (1) • Cat Diarrhea (1) • Dog Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Neurologic
Tiredness (1) • Dog Seizure NOS (1) • Dog

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy (endoparasite) - tapeworm (1) • Dog Lack of efficacy (endoparasite) - roundworm NOS (1) • Dog Lack of efficacy (endoparasite) - hookworm (1) • Dog Lack of efficacy (bacteria) - Borrelia (1) • Dog

Showing top 5 for Effectiveness.

Other
Not eating (1) • Dog Death (1) • Dog Anaemia NOS (1) • Dog Accidental exposure (1) • Cat Cough, hacking • Dog
Show more (1)
Bilirubinuria • Dog

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.

No case-level openFDA reports are linked for this medication yet.

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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.