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Animal NDC 66104-9601-1 V-max 50

Virginiamycin

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-9601-1
Proprietary Name V-max 50 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
    Important: Must be diluted in feed before useFollow Directions on Back PanelV-Max is a registered trademark of Phibro Animal Health CorporationPhibro Animal Health Corporation, Teaneck, NJ 07666Approved by FDA under NADA # 140-9988812000101-9141-06NET CONTENTS: 50 lb (22.7 kg)Distributed by:PHIBRO ANIMAL HEALTH, INC.Teaneck, NJ 07666, USA NOT FOR HUMAN USERESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED
Active Ingredient(s)
  • Virginiamycin
Inactive Ingredient(s)
  • CALCIUM CARBONATE (H0G9379FGK)
  • MINERAL OIL (T5L8T28FGP)
  • CARBOXYMETHYLCELLULOSE SODIUM (K679OBS311)
  • CALCIUM CARBONATE (H0G9379FGK)
  • MINERAL OIL (T5L8T28FGP)
  • CARBOXYMETHYLCELLULOSE SODIUM (K679OBS311)
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 50 Images

V-max 50 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 : 11%

(Contains 50 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 :



Processed grain by-products, roughage products, calcium carbonate, carboxymethylcellulose, mineral oil


Indications & Usage



Important: Must be diluted in feed before use

Follow Directions on Back Panel

V-Max is a registered trademark of Phibro Animal Health Corporation

Phibro Animal Health Corporation, Teaneck, NJ 07666

Approved by FDA under NADA # 140-998

8812000

101-9141-06

NET CONTENTS: 50 lb (22.7 kg)

Distributed by:

PHIBRO ANIMAL HEALTH, INC.

Teaneck, NJ 07666, USA

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED


(50 G Virginiamycin Activity Per Lb)For Use In Complete Feeds For Cattle Fed In Confinement For Slaughter As Specified Belowdirections 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 abscesse

85–240

13.5–16.0

Caution: Not for use in animals intended for breeding.


Mixing Directions



Preparation ofType B Medicated Feeds for cattle fed in confinement for slaughter—Thoroughly mix the following amounts of V-Max 50 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 50 Type A Medicated Article per ton of supplement

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

5

10

20

40

100

200

250

500

1,000

2,000

5,000

10,000

Preparation of Type C Medicated Feed for cattle fed in confinement for slaughter:

From Type B 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 50 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 prepared from V-Max 50 Type B 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

From Type A Medicated Article: V-Max 50 Type A Medicated Article must be diluted to a Type C Medicated Feed before being fed. Thoroughly mix the Type A Medicated Article 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 3.

An intermediate blending step, consistent with the blending equipment specifications, should be performed to ensure adequate mixing.

Table 3. Type C Medicated Feed prepared from V-Max 50 Type A Medicated Article

lb of V-Max 50 Type A Medicated Article per ton of complete feed

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

0.27

0.32

13.5

16.0

Feed continuously as sole ration


Store At Or Below 25°C/77F°, Excursions Permitted Up To 40Oc (104Of)



Close container after use


V-Max 50



V-Max 50 Label


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