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Animal NDC 66104-8902-1 V-max

Virginiamycin

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-8902-1
Proprietary Name V-max 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 slaughterVirginiamycin required mg/hd/dayVirginiamycin (g/tons) of complete feed (90% dry matter basis)Reduction of incidence of liver abscesses85–24013.5–16.0Caution: Not for use in animals intended for breeding.
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.

V-max Images

V-max 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



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

301-8018-09

V-Max is a registered trademark Phibro Animal Health Corporation

NET CONTENTS: 100 lb (45.3 kg)

Distributed by:

PHIBRO ANIMAL HEALTH CORPORATION

Teaneck, NJ 07666, USA

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 Feeds for cattle fed in confinement for slaughter—Thoroughly mix the following amounts of V-Max Type A Medicated Article to make 1 ton of Type B Medicated Feed to provide the concentrations shown in Table 1. An intermediate blending step, consistent with the mixing equipment specifications, should be performed to ensure adequate mixing.

Table 1. Type B Medicated Feed

lb of V-Max Type A Medicated Article per ton of supplement

Virginiamycin concentration in Type B Medicated Feed (g/ton)

1.1

2.2

4.4

8.8

22.0

44.0

250

500

1,000

2,000

5,000

10,000

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 V-Max 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 2.

Table 2. Type C Medicated Feed

lb of a 500g/ton Type B Medicated Feed per ton of complete feed

lb of a 1,000 g/ton Type B Medicated Feed per ton of complete feed

lb of a 5,000 g/ton Type B Medicated Feed per ton of complete feed

lb of a 10,000 g/ton Type B Medicated Feed per ton of complete feed

Virginiamycin concentration in complete feed 90% dry matter basis (g/ton)

54

27

5.4

2.7

13.5

64

32

6.4

3.2

16.0


Indications & Usage



NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED


Vmax Label



VMax Label


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