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Animal NDC 54771-1128-0 Robenz

Robenidine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-1128-0
Proprietary Name Robenz 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 Robenidine Hydrochloride 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 Otc Type A Medicated Article Animal Drug
Usage Information
    Broiler chickensAs an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima and E. necatrix in broiler chickens only.
Active Ingredient(s)
  • Robenidine Hydrochloride
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 NADA048486 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.

Robenz Images

Robenz 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



Active Drug Ingredient



Robenidine hydrochloride 30 grams per pound (6.6%) in a carrier suitable for incorporation in feed.


Indications



Broiler chickens

As an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima and E. necatrix in broiler chickens only.


Use Directions



Mix 1 pound of Robenz® Type A Medicated Article in one ton of feed to provide 30 grams per ton (0.0033%) robenidine hydrochloride concentration in feed. Feed continuously as the sole ration.


Caution



Type C feeds containing Robenz robenidine hydrochloride must be fed within 50 days from the date of manufacture. Do not use this product in Type B or C medicated feeds containing bentonite


Warning



Do not feed to chickens producing eggs for food. Withdraw 5 days prior to slaughter.


Note



Manufacture of Type B and C feeds from this product requires a medicated feed mill license.

Labels for feeds containing Robenz 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.