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Animal NDC 54771-1446-0 Rofenaid 40

Sulfadimethoxine And Ormetoprim

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-1446-0
Proprietary Name Rofenaid 40 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Sulfadimethoxine And Ormetoprim What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Vfd Type A Medicated Article Animal Drug
Active Ingredient(s)
  • Sulfadimethoxine
  • Ormetoprim
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA040209 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Rofenaid 40 Images

Rofenaid 40 Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



RofenAid
40

Sulfadimethoxine & Ormetoprim

Type A Medicated Article

Antibacterial

Anticoccidial

For use in broiler, replacement (breeder and layer) chickens, turkeys, ducks and chukar partridges only.


Active Drug Ingredients



Sulfadimethoxine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113.5 grams per pound (25%),

Ormetoprim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68.1 grams per pound (15%)

in a carrier suitable for incorporation in feed.

For use in manufacturing medicated feeds only


Chickens



Broiler and replacement (breeder and layer) chickens

Indications:

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 Pasteurella multocida (fowl cholera).

Use directions:

Add 1 lb of RofenAid 40 to one ton of feed to provide 0.02% (113.5 g/ton [0.0125%] sulfadimethoxine and 68.1 g/ton [0.0075%] ormetoprim) concentration in feed. Feed continuously as the sole ration.

Warning:

Do not feed to chickens over 16 weeks (112 days) of age.


Turkeys



Indications:

As an aid in the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis; for the prevention of bacterial infections caused by Pasteurella multocida (fowl cholera).

Use directions:

Add 1/2 lb of RofenAid 40 to one ton of feed to provide 0.01% (56.75 g/ton [0.00625%] sulfadimethoxine and 34.05 g/ton [0.00375%] ormetoprim) concentration in feed. Feed continuously as the sole ration.


Ducks



Ducks, including breeding ducks

 Indications:

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

Use directions:

Add 2 lbs of RofenAid 40 to one ton of feed to provide 0.04% (227 g/ton [0.025%] sulfadimethoxine and 136.2 g/ton [0.015%] ormetoprim) concentration in feed. Medication should be started at the first signs of infection. Feed for 7 days as the sole ration.

 

Ducks

Indications:

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

Use directions:

Add 4 lbs of RofenAid 40 to one ton of feed to provide 0.08% (454 g/ton [0.050%] sulfadimethoxine and 272.4 g/ton [0.030%] ormetoprim) concentration in feed. Medication should be started at the first signs of infection. Feed for 7 days as the sole ration.

Caution:

Not for breeding ducks. The safety of feeding sulfadimethoxine and ormetoprim at levels higher than 0.025% and 0.015%, respectively, in breeding ducks has not been established.


Chukar Partridges



Indications:

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

Use directions:

Add 1 lb of RofenAid 40 to one ton of feed to provide 0.02% (113.5 g/ton [0.0125%] sulfadimethoxine and 68.1 g/ton [0.0075%] ormetoprim) concentration in feed. Feed continuously as the sole ration to young birds up to 8 weeks of age.

Caution:

The safety of feeding RofenAid 40 to breeding stock has not been established.


Warning



Do not feed to turkeys and ducks producing eggs for food. Withdraw 5 days prior to slaughter of broiler and replacement chickens, turkeys and ducks.


Note



Manufacture of Type B or C feeds from this product requires a Medicated Feed Mill License.

Labels for feeds containing RofenAid 40 must contain appropriate indications, limitations and warnings as well as required feed ingredient information.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.