FDA.reportPublic FDA data

Robenz

Manufacturer
Zoetis Inc. | Zoetis LLC
Effective date
2020-04-08
Label type
OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:40:44

Label at a glance#

ProductRobenz
Active ingredientROBENIDINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Robenidine Hydrochloride
Type A Medicated Article
Coccidiostat

Active drug ingredient

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

For use in manufacturing medicated feeds only

Indications

VETERINARY INDICATIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

RESIDUE WARNING SECTION

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

Note

SPL UNCLASSIFIED SECTION

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

Take TimeTake Time

PRINCIPAL DISPLAY PANEL - 50 LB Bag

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 LB Bag Label
50 LB Bag Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54771-1128-0Robenz22.68 kg in 1 BAGPOWDER22.682

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-1128ROBENZ (ROBENIDINE HYDROCHLORIDE) POWDER [ZOETIS INC.]21 package rows20200418_f86501dd-61c8-451b-ad5e-562e349fbd37.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54771-112854771-1128-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
ROBENIDINE HYDROCHLORIDE8STT15Y392ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.