Animal NDC 66104-1501-3 Stafac 500
Virginiamycin
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 66104-1501-3 |
| Proprietary Name | Stafac 500 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 |
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| Active Ingredient(s) |
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| Inactive Ingredient(s) |
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| 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 500 Images
Stafac 500 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
Other
Type A Medicated Article Mix with swine and poultry feed
Active Drug Ingredient
Virginiamycin : 50%
(Contains 227g 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
For Further Manufacture Only.
Follow Directions For Use.
Approved by FDA under NADA # 091-467
301-8001-10
Stafac is a registered trademark of Phibro Animal Health Corporation
Distributed by: Phibro Animal Health Corporation, Teaneck, NJ 07666
Made in Canada
Directions For Use
Mixing Directions—Swine
Stafac 500 Type A Medicated Article must be thoroughly mixed in the feed to assure even distribution. Determine the appropriate amount of Stafac 500 required from the table below. Dilute Stafac 500 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 500 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 | 200 g | 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 | 200 g 100 g | 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 | 50 g | 0.57 mg |
►Caution: Not for use in breeding swine over 120 pounds.◄ | |||
Mixing Directions—Poultry Mix 100 g Stafac 500 with enough of one of the feed ingredients to make 10 lb of an intermediate mix. Add 1 lb of the intermediate mix 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 500 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 | 40 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 500
Stafac 500
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.