Label: STAFAC 500- virginiamycin powder

  • NDC Code(s): 66104-1501-1, 66104-1501-2, 66104-1501-3, 66104-1501-9
  • Packager: Phibro Animal Health
  • Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 6, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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

  • For use in swine and poultry feeds as specified below

  • 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 500Stafac 500

  • INGREDIENTS AND APPEARANCE
    STAFAC 500 
    virginiamycin powder
    Product Information
    Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:66104-1501
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VIRGINIAMYCIN (UNII: C49WS9N75L) (VIRGINIAMYCIN - UNII:C49WS9N75L) VIRGINIAMYCIN227 g  in 0.45 kg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66104-1501-945.3 kg in 1 DRUM
    2NDC:66104-1501-125 kg in 1 BOX
    3NDC:66104-1501-2600 kg in 1 BAG
    4NDC:66104-1501-3800 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA09146704/01/2010
    Labeler - Phibro Animal Health (006989008)
    Registrant - Phibro Animal Health (006989008)