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Roxee Medication Guide

Ormetoprim, Sulfadimethoxine

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 Tablet Multiple FDA labelers Official label facts Owner quick guide first
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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, 10:41 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).
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Ormetoprim, Sulfadimethoxine

Ormetoprim, Sulfadimethoxine

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

Both Tablet Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

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

Ormetoprim, Sulfadimethoxine

For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination. For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination. As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati ; as an aid in the prevention of bacterial infections caused by Haemophilus gallinarum (infectious coryza), Escherichia coli (colibacillosis) and P. multocida (fowl cholera). Species commonly shown: Both, Dog, Salmonids, Reared.

Generic name
Ormetoprim, Sulfadimethoxine
Brand names
Primor® Tablets, Romet®-30, Rofenaid® 40, Rofenaid 40
Manufacturer
Multiple FDA labelers
Species
Both, Dog, Salmonids, Catfish
Dosage forms
Tablet, Type A Medicated Article
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Primor® Tablets Romet®-30 Rofenaid® 40 Rofenaid 40 ROMET 30
Dosage forms
Tablet Type A Medicated Article

Indications / Uses

For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination. For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination. As an aid in the prevention of coccidiosis caused by Eimeria tenella , E. necatrix , E. acervulina , E. maxima , E. brunetti , and E. mivati ; as an aid in the prevention of bacterial infections caused by Haemophilus gallinarum (infectious coryza), Escherichia coli (colibacillosis) and P. multocida (fowl cholera).

Warnings / Contraindications

Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter. Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish. Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter.

  • Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter. Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish. Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter.

FAQ

Both, Dog, Salmonids, Reared, Catfish, Reared, Duck, Excluding Laying Eggs For Human Consumption, Breeding, Up to 16 weeks (112 days) of age, Broilers, Replacements, Excluding turkeys producing eggs for human consumption, Chukar Partridges, Up To 8 Weeks Of Age

Yes. Roxee shows this as prescription-only.

Tablet, Type A Medicated Article

Related Conditions

Abscesses (cat bite abscess) Coccidiosis Urinary tract infection (cystitis)

Source Transparency

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Pet Owner Quick Guide

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Used for:

As an aid in the prevention of coccidiosis caused by Eimeria tenella , E. necatrix , E. acervulina , E. maxima , E. brunetti , and E. mivati ; as an aid in the prevention of bacterial infections caused by Haemophilus gal...

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:

  • Administer for 5 consecutive days
  • Withdraw 42 days before release as stocker fish or slaughter
  • Withdraw 3 days before slaughter or release as stocker fish
  • Feed as sole ration
  • Do not feed to chickens over 16 weeks (112 days) of age
  • Withdraw 5 days before slaughter

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 Limited Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Ormetoprim, Sulfadimethoxine; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA adverse-event data
Safety signal coverage No signal rollup

No source-backed adverse-reaction rollup is linked yet. That is a data gap, not proof that no reactions occur.

Source: openFDA adverse-event data
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 adverse-event data
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

Reaction signal map Limited data

No source-backed adverse-reaction rollup is linked yet for this medication. Use the owner watch list, official documents, and veterinary guidance.

What your vet may verify

Fit for this patient Vet check

Verify whether Ormetoprim, Sulfadimethoxine 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

Administer for 5 consecutive days, Withdraw 42 days before release as stocker fish or slaughter, Withdraw 3 days before slaughter or release as stocker fish, Feed as sole ration, Do not feed to chickens over 16 weeks (112 days) of age

Call sooner if Escalation

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

Bottom line: Roxee has limited reaction-signal depth for Ormetoprim, Sulfadimethoxine right now. Use veterinary instructions, official documents, and direct clinic guidance for decisions.
Vet source depth
  1. openFDA adverse-event data · openfda · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. EA · document · documents
  8. FONSI · 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:

  • Administer for 5 consecutive days
  • Withdraw 42 days before release as stocker fish or slaughter
  • Withdraw 3 days before slaughter or release as stocker fish
  • Feed as sole ration
  • Do not feed to chickens over 16 weeks (112 days) of age

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
Breeding, Broilers, Catfish, Chukar Partridges, Dog, Duck, Excluding turkeys producing eggs for human consumption, Replacements, Salmonids, Up to 16 weeks (112 days) of age
Indication / use
As an aid in the prevention of coccidiosis caused by Eimeria tenella , E. necatrix , E. acervulina , E. maxima , E. brunetti , and E. mivati ; as an aid in the prevention of bacte…
Form / route / dose
Form: Tablet, Type A Medicated Article
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter. Administer for 5 conse…
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: Multiple FDA labelers
Form: Tablet, Type A Medicated Article
Identifiers:
NADA: 100929 NADA: 125933 NADA: 40209 NDC Package: 15331-0103-1 NDC Package: 54771-1446-0 NDC Product: 15331 NDC Product: 54771
Source metadata:

Warnings / Contraindications

Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter. Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish. Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter.

  • High: Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter. Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish. Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter.
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.

040-209 Official label / PI · EA 040-209 Official label / PI · FONSI 125-933 Official label / PI · EA

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

4

SPL

5

FOI

4

040-209

Official label / PI · EA

Open original

040-209

Official label / PI · FONSI

Open original

125-933

Official label / PI · EA

Open original

125-933

Official label / PI · FONSI

Open original

Rofenaid® 40

SPL · SPL

Open original
FDA Structured Product Label

Rofenaid® 40

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

Sponsor
Phibro Animal Health Corp.
NADA
40209
Status
VFD
Form
Type A Medicated Article
Route
Oral
Species
Duck • Breeding • Up to 16 weeks (112 days) of age • Broilers • Replacements • Excluding turkeys producing eggs for human consumption • Chukar Partridges
Composition / specifications
Each pound of Type A medicated article contains 113.5 grams sulfadimethoxine (25%) and 68.1 grams ormetoprim (15%)

Chickens (broilers and replacements)

Indication

As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; as an aid in the prevention of bacterial infections caused by Haemophilus gallinarum (infectious coryza), Escherichia coli (colibacillosis) and P. multocida (fowl cholera).

Dosage

Sulfadimethoxine, 113.5 grams per ton of feed (0.0125 percent), and ormetoprim, 68.1 grams per ton of feed (0.0075 percent).

Limitations

Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter.

Turkeys

Indication
As an aid in the prevention of coccidiosis caused by E. adenoeides, E. gallopavonis, and E. meleagrimitis and for the prevention of bacterial infections caused by P. multocida (fowl cholera).
Dosage
Sulfadimethoxine, 56.75 grams (0.00625 percent) per ton of feed plus ormetoprim, 34.05 grams (0.00375 percent) per ton of feed.
Limitations

Do not feed to turkeys producing eggs for food. Withdraw 5 days before slaughter.

Ducks (including breeding ducks)

Indication

As an aid in the control of bacterial infections due to P. multocida (fowl cholera) in ducks including breeding ducks.

Dosage

Sulfadimethoxine, 227 grams per ton of feed (0.025 percent), and ormetoprim, 136.2 grams per ton of feed (0.015 percent).

Limitations

Feed as sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; do not feed to ducks producing eggs for food.

Ducks

Indication

As an aid in the control of bacterial infections due to Escherichia coli, Riemerella anatipestifer (strains 2, 3, and 4), and severe challenge of P. multocida (fowl cholera).

Dosage

Sulfadimethoxine, 454 grams per ton of feed (0.05 percent), and ormetoprim, 272.4 grams per ton of feed (0.03 percent).

Limitations

Feed as sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; not for breeding ducks; do not feed to ducks producing eggs for food.

Chukar partridges

Indication
For prevention of coccidiosis caused by Eimeria kofoidi and E. legionensis.
Dosage

Sulfadimethoxine, 113.5 grams per ton of feed (0.0125 percent), and ormetoprim, 68.1 grams per ton of feed (0.0075 percent).

Limitations
Feed continuously to young birds up to 8 weeks of age as sole ration.

Romet®-30

SPL · SPL

Open original
FDA Structured Product Label

Romet®-30

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

Sponsor
Pharmaq AS
NADA
125-933
Status
VFD
Form
Type A Medicated Article
Route
Oral
Species
Salmonids • Catfish
Composition / specifications
Type A medicated articles: 25 percent sulfadimethoxine and 5 percent ormetoprim.

Fresh-water reared salmonids

Indication

For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination.

Dosage
50 milligrams of active ingredients per kilogram of body weight per day.
Limitations
Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter.

Catfish

Indication

For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination.

Dosage
50 milligrams of active ingredients per kilogram of body weight per day.
Limitations
Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish.

Primor® Tablets

SPL · SPL

Open original
FDA Structured Product Label

Primor® Tablets

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

Sponsor
Zoetis Inc.
NADA
100-929
Status
RX
Form
Tablet
Route
Oral
Species
Dog
Composition / specifications
Each tablet contains 120 milligrams (100 milligrams of sulfadimethoxine and 20 milligrams of ormetoprim), 240 milligrams (200 milligrams of sulfadimethoxine and 40 milligrams of ormetoprim), 600 milligrams (500 milligrams of sulfadimethoxine and 100 milligrams of ormetoprim), or 1200 milligrams (1,000 milligrams of sulfadimethoxine and 200 milligrams of ormetoprim).

Dogs

Indication
Treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli and urinary tract infections caused by Escherichia coli, Staphylococcus species, and Proteus mirabilis susceptible to ormetoprim-potentiated sulfadimethoxine.
Dosage
On the first day of treatment, administer 25 milligrams per pound (55 milligrams per kilogram) of body weight. Then follow with a daily dosage of 12.5 milligrams per pound (27.5 milligrams per kilogram) of body weight.
Limitations
Continue treatment until patient is asymptomatic for 48 hours, but do not exceed a total of 21 consecutive days. Maintain adequate water intake during the treatment period. Safety in breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

ROMET 30 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for ROMET 30. Use the source link for the full official labeling record.

Rofenaid 40 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Rofenaid 40. Use the source link for the full official labeling record.

ucm049548.pdf

FOI · FOI

Open original

UCM452233.pdf

FOI · FOI

Open original

N100929_Supp_8_5_1996.pdf

FOI · FOI

Open original

N 100929_Orig_11_24_1989.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, 10:41 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: ROMET 30 Rofenaid 40
Manufacturer mapping: Multiple FDA labelers
Catalog species: Both • FDA-labeled species: Breeding, Broilers, Catfish, Chukar Partridges, Dog, Duck, Excluding turkeys producing eggs for human consumption, Replacements, Salmonids, Up to 16 weeks (112 days) of age
Rx/OTC: RX, VFD
Form/route: Tablet, Type A Medicated Article • Oral
Applications: NADA 40209 • NADA 125-933 • NADA 100-929
NDC: Packages 15331-0103-1 54771-1446-0 • Products 15331 54771
Documents: 8 (FOI: 4) • SPL: 3 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
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
  • Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter. Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish. Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter. (Contraindication, High)

Identifiers & Packages

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

Identifiers
NADA: 100929 NADA: 125933 NADA: 40209 NDC Package: 15331-0103-1 NDC Package: 54771-1446-0 NDC Product: 15331 NDC Product: 54771
Package NDC Product NDC Form / Route Status
15331-0103-1 15331 -
54771-1446-0 54771 -

Enriched Documents

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

  • ROMET 30 SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Rofenaid 40 SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ucm049548.pdf • FOI summary • Official • June 17, 2025
    FDA FOI summary for application 40209
  • UCM452233.pdf • FOI summary • Official • Dec. 27, 2022
    FDA FOI summary for application 125933
  • N 100929_Orig_11_24_1989.pdf • FOI summary • Official • July 12, 2017
    FDA FOI summary for application 100929
  • N100929_Supp_8_5_1996.pdf • FOI summary • Official • July 12, 2017
    FDA FOI summary for application 100929

Data Sources & Change Log

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

Official 126 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter. Administer for 5 consecutive days. Withdraw 3 days before slau… (Official, 2026-04-22)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-22)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-22)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-21)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-20)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-13)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-12)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-12)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-11)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-11)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-10)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-09)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-08)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-07)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-06)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-05)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-04)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-03)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-02)
  • indications: This supplemental Application amends the NADA to provide for the use of Primor® Tablets for the treatment of urinary tract infections caused by certain bacter… (Official, 2026-06-01)
Recent Revisions
  • 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

FDA Products & Applications (Animal Drugs @ FDA)

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

Product Sponsor Application Status Published
Rofenaid® 40
VFD
Ormetoprim Sulfadimethoxine
Type A Medicated Article • Oral
Label highlights
Official documents
Phibro Animal Health Corp. NADA 40209 Approved Jun 17, 2025
Romet®-30
VFD
Ormetoprim Sulfadimethoxine
Type A Medicated Article • Oral
Label highlights
Official documents
Pharmaq AS NADA 125-933 Approved Dec 27, 2022
Primor® Tablets
RX
Ormetoprim Sulfadimethoxine
Tablet • Oral
Label highlights
Official documents
Zoetis Inc. NADA 100-929 Approved Jul 12, 2017

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: Duck • Breeding • Up to 16 weeks (112 days) of age • Broilers • Replacements • Excluding turkeys producing eggs for human consumption • Chukar Partridges
Composition / specifications
Each pound of Type A medicated article contains 113.5 grams sulfadimethoxine (25%) and 68.1 grams ormetoprim (15%)
Chickens (broilers and replacements)
Indication

As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; as an aid in the prevention of bacterial infections caused by Haemophilus gallinarum (infectious coryza), Escherichia coli (colibacillosis) and P. multocida (fowl cholera).

Dosage

Sulfadimethoxine, 113.5 grams per ton of feed (0.0125 percent), and ormetoprim, 68.1 grams per ton of feed (0.0075 percent).

Limitations

Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter.

Turkeys
Indication
As an aid in the prevention of coccidiosis caused by E. adenoeides, E. gallopavonis, and E. meleagrimitis and for the prevention of bacterial infections caused by P. multocida (fowl cholera).
Dosage
Sulfadimethoxine, 56.75 grams (0.00625 percent) per ton of feed plus ormetoprim, 34.05 grams (0.00375 percent) per ton of feed.
Limitations

Do not feed to turkeys producing eggs for food. Withdraw 5 days before slaughter.

Ducks (including breeding ducks)
Indication

As an aid in the control of bacterial infections due to P. multocida (fowl cholera) in ducks including breeding ducks.

Dosage

Sulfadimethoxine, 227 grams per ton of feed (0.025 percent), and ormetoprim, 136.2 grams per ton of feed (0.015 percent).

Limitations

Feed as sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; do not feed to ducks producing eggs for food.

Ducks
Indication

As an aid in the control of bacterial infections due to Escherichia coli, Riemerella anatipestifer (strains 2, 3, and 4), and severe challenge of P. multocida (fowl cholera).

Dosage

Sulfadimethoxine, 454 grams per ton of feed (0.05 percent), and ormetoprim, 272.4 grams per ton of feed (0.03 percent).

Limitations

Feed as sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; not for breeding ducks; do not feed to ducks producing eggs for food.

Chukar partridges
Indication
For prevention of coccidiosis caused by Eimeria kofoidi and E. legionensis.
Dosage

Sulfadimethoxine, 113.5 grams per ton of feed (0.0125 percent), and ormetoprim, 68.1 grams per ton of feed (0.0075 percent).

Limitations
Feed continuously to young birds up to 8 weeks of age as sole ration.

FDA page: Open in Animal Drugs @ FDA

Species: Salmonids • Catfish
Composition / specifications
Type A medicated articles: 25 percent sulfadimethoxine and 5 percent ormetoprim.
Fresh-water reared salmonids
Indication

For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination.

Dosage
50 milligrams of active ingredients per kilogram of body weight per day.
Limitations
Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter.
Catfish
Indication

For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination.

Dosage
50 milligrams of active ingredients per kilogram of body weight per day.
Limitations
Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish.

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
Each tablet contains 120 milligrams (100 milligrams of sulfadimethoxine and 20 milligrams of ormetoprim), 240 milligrams (200 milligrams of sulfadimethoxine and 40 milligrams of ormetoprim), 600 milligrams (500 milligrams of sulfadimethoxine and 100 milligrams of ormetoprim), or 1200 milligrams (1,000 milligrams of sulfadimethoxine and 200 milligrams of ormetoprim).
Dogs
Indication
Treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli and urinary tract infections caused by Escherichia coli, Staphylococcus species, and Proteus mirabilis susceptible to ormetoprim-potentiated sulfadimethoxine.
Dosage
On the first day of treatment, administer 25 milligrams per pound (55 milligrams per kilogram) of body weight. Then follow with a daily dosage of 12.5 milligrams per pound (27.5 milligrams per kilogram) of body weight.
Limitations
Continue treatment until patient is asymptomatic for 48 hours, but do not exceed a total of 21 consecutive days. Maintain adequate water intake during the treatment period. Safety in breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination. For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination. As an aid in the prevention of coccidiosis caused by Eimeria tenella , E. necatrix , E. acervulina , E. maxima , E. brunetti , and E. mivati ; as an aid in the prevention of bacterial infections caused by Haemophilus gallinarum (infectious coryza), Escherichia coli (colibacillosis) and P. multocida (fowl cholera).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter. Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish. Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter.

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.

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