ROBENZ- robenidine hydrochloride powder

Robenz by

Drug Labeling and Warnings

Robenz by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc., Zoetis LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Robenidine Hydrochloride
Type A Medicated Article
Coccidiostat

Active drug ingredient

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

PURPOSE

For use in manufacturing medicated feeds only

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.

SPL UNCLASSIFIED SECTION

Restricted Drug (California) - Use Only as Directed.

Not for human use.

Store below 25°C (77°F), excursions permitted to 37°C (99°F).

Approved by FDA under NADA # 048-486

SPL UNCLASSIFIED SECTION

zoetis

Manufactured by:
Zoetis LLC
Salisbury, MD 21801

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Product of Spain

40027288

PRINCIPAL DISPLAY PANEL - 50 LB Bag

INGREDIENTS AND APPEARANCE

ROBENZ 
robenidine hydrochloride powder

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 54771-1128
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ROBENIDINE HYDROCHLORIDE (UNII: 8STT15Y392) (ROBENIDINE - UNII:4888ME6C4E)	ROBENIDINE HYDROCHLORIDE	30 g  in 0.45 kg

Product Characteristics
Color	BROWN (Buff to Tan)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-1128-0	22.68 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA048486	01/01/2009

Labeler - Zoetis Inc. (828851555)

Establishment
Name	Address	ID/FEI	Business Operations
Zoetis LLC		069370112	MANUFACTURE