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Animal NDC 66104-8815-0 Stafac 50

Virginiamycin

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-8815-0
Proprietary Name Stafac 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
    (50 g virginiamycin activity per lb)For use in swine and poultry feeds as specified below
Active Ingredient(s)
  • Virginiamycin
Inactive Ingredient(s)
  • RICE BRAN (R60QEP13IC)
  • 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 NADA091467 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.

Stafac 50 Images

Stafac 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



Active Drug Ingredient



Virginiamycin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11%

(Contains 50 g virginiamycin activity per lb)


Ingredients:



Processed grain by-products, roughage products, calcium carbonate,

carboxymethylcellulose, mineral oil


Caution:



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

For further manufacture only.

Follow Directions on Back Panel

Stafac is registered trademark of Phibro Animal Health Corporation

Phibro Animal Health Corporation, Teaneck, NJ 07666

Net Weight 50 lb (22.6 kg)

Distributed by:

Phibro Animal Health Corporation

Teaneck, NJ 07666

Approved by FDA under NADA # 091-467

9910000

101-9107-10


Indications & Usage



(50 g virginiamycin activity per lb)

For use in swine and poultry feeds as specified below


Directions For Use



Mixing Directions—Swine

Stafac 50 Type A Medicated Article must be thoroughly mixed in the feed to assure even distribution. Determine the appropriate amount of Stafac 50 required from the table below. Dilute Stafac 50 with a portion of one of the feed ingredients (enough to make a quantity equal to 10 lb per ton) before final mixing.

Swine

Required level of virginiamycin activity per ton of Type C Medicated Feed (complete feed)

Required amount of Stafac 50 per ton of Type C Medicated Feed (complete feed)

Amount of virginiamycin activity provided to animal per lb of body weight per day

Treatment of swine dysentery in nonbreeding swine weighing over 120 lb

100 g for

2 weeks

2 lb

2.27 mg

Treatment and control of swine dysentery in swine weighing up to 120 lb

100 g for 2 weeks followed by 50 g

2 lb

1 lb

2.27 mg

1.14 mg

Aid in control of swine dysentery in swine weighing up to 120 lb

For use in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred

25 g

8 oz

0.57 mg

CAUTION: Not for use in breeding swine over 120 lbs.

Mixing Directions—Poultry

Mix 1 lb of Stafac 50 with 9 lb of feed ingredients to make 10 lb of an intermediate mix to contain 5 g/lb virginiamycin. Add 1 lb of the intermediate feed premix for each 5 g of virginiamycin needed to medicate a ton of feed.

Poultry

Required level of virginiamycin activity per ton of Type C Medicated Feed (complete feed)

Required amount of Stafac 50 per ton of Type C Medicated Feed (complete feed)

For use in broiler chickens

Prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin

20 g

180 g

Not for Use in Laying Chickens


Storage And Handling



Feed Continuously as Sole Ration

Store At Or Below 25oC (77oF), Excursions Permitted Up to 40oC (104oF)

Close Container After Use

Not for Human Use

Restricted Drug (California) – Use Only As Directed


Stafac 50



Stafac 50


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