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Animal NDC 66104-6236-2 Hepaflex

Virginiamycin

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-6236-2
Proprietary Name Hepaflex 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 Virginiamycin 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 Phibro Animal Health
Product Type Vfd Type A Medicated Article Animal Drug
Usage Information
     Cattle fed in confinement for slaughter Virginiamycin required mg/hd/day Virginiamycin (g/tons) of complete feed (90% dry matter basis) Reduction of incidence of liver abscesses 85-240       13.5-16.0Caution: Not for use in animals intended for breeding.Mixing DirectionsType B medicated feed for cattle fed in confinement for slaughter - Thoroughly mix 4.4 lb of HepafleX Type A Medicated Article per ton of Type B medicated feed to provide 1000 g/ton virginiamycin.An intermediate blending step, consistent with the mixing equipment specifications, should be performed to ensure adequate mixing.Type C medicated feedThe Type B medicated feed must be diluted to a Type C medicated feed before being fed. Prepare a Type B medicated feed as described above. Thoroughly mix the Type B medicated feed to make 1 ton of Type C medicated feed to provide 13.5–16.0 g of virginiamycin per ton of complete feed on a 90% dry matter basis using the examples provided in Table 1.Table 1. Type C medicated feedlb of a 1,000 g/ton Type Bmedicated feed per ton of complete feed Virginiamycin concentration in complete feed90% dry matter basis (g/ton) 27 13.5 32 16.0 Feed continuously as sole ration
Active Ingredient(s)
  • Virginiamycin
Inactive Ingredient(s)
  • CALCIUM CARBONATE (H0G9379FGK)
  • MINERAL OIL (T5L8T28FGP)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (K679OBS311)
  • SOYBEAN OIL (241ATL177A)
  • RICE BRAN (R60QEP13IC)
  • CALCIUM CARBONATE (H0G9379FGK)
  • MINERAL OIL (T5L8T28FGP)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (K679OBS311)
  • SOYBEAN OIL (241ATL177A)
  • RICE BRAN (R60QEP13IC)
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 NADA140998 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.

Hepaflex Images

Hepaflex 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



Warnings And Precautions



To be mixed in cattle feed


Active Drug Ingredient



Virginiamycin : 50%

(Contains 227 g virginiamycin activity per lb)


Caution:



CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.


Inert Ingredients:



Calcium carbonate, carboxymethylcellulose, mineral oil


Other



Important: Must be diluted in feed before use

Follow Directions For Use

Approved by FDA under NADA # 140-998

102-8409-1

HepafleX, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. 

NET WEIGHT: 55 lb (25kg)

Distributed by:

Elanco US Inc.

Indianapolis, IN  46221

Made in Canada

SKU:
LOT No.:
DATE OF EXPIRATION:
Distributed by:
Elanco US Inc.
Indianapolis, IN 46221
Made in Canada.


For Use In Complete Feeds For Cattle Fed In Confinement For Slaughterdirections For Use



 Cattle fed in confinement for slaughter Virginiamycin required mg/hd/day Virginiamycin (g/tons) of complete feed (90% dry matter basis)
 Reduction of incidence of liver abscesses 85-240       13.5-16.0
Caution: Not for use in animals intended for breeding.

Mixing Directions


Type B medicated feed for cattle fed in confinement for slaughter - Thoroughly mix 4.4 lb of HepafleX Type A Medicated Article per ton of Type B medicated feed to provide 1000 g/ton virginiamycin.
An intermediate blending step, consistent with the mixing equipment specifications, should be performed to ensure adequate mixing.


Type C medicated feed
The Type B medicated feed must be diluted to a Type C medicated feed before being fed. Prepare a Type B medicated feed as described above. Thoroughly mix the Type B medicated feed to make 1 ton of Type C medicated feed to provide 13.5–16.0 g of virginiamycin per ton of complete feed on a 90% dry matter basis using the examples provided in Table 1.

Table 1. Type C medicated feed

lb of a 1,000 g/ton Type B
medicated feed per ton of complete feed		 Virginiamycin concentration in complete feed
90% dry matter basis (g/ton)
 27 13.5
 32 16.0

 Feed continuously as sole ration


Storage And Handling



Store At Or Below 25°C (77°F), Excursions Permitted Up To 40°C (104°F)
Close container after use


Indications & Usage



Not For Human Use
Restricted Drug (California) – Use Only as Directed


Hepaflex



Label


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