Label: VITAMIN B12- cyanocobalamin injection

  • NDC Code(s): 11695-1230-5
  • Packager: Covetrus North America
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 19, 2023

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

  • Recommended use:

    For use in managing Vitamin B12 deficiencies associated with cobalt deficiency, inadequate intake, or intestinal malabsorption in
    cattle, sheep, swine, and horses.

  • Each mL of sterile aqueous solution contains:

    Cyanocobalamin (Vitamin B12) 5000 mcg, Benzyl Alcohol (preservative) 1.0% v/v, Sodium Chloride 0.22% w/v, Ammonium
    Sulfate 0.1% w/v, Citric Acid 0.01% w/v, Sodium Citrate 0.008% w/v.

  • Dosage and Administration:

    Inject subcutaneously or intramuscularly. Dosage may be repeated at weekly intervals if
    necessary. May be injected intravenously at the discretion of the veterinarian.
    Cattle and Horses: 0.2 to 0.4 mL, Swine and Sheep: 0.1 mL

  • STORAGE AND HANDLING

    Store at temperature between 15° and 30°C (59° - 86°F). Avoid exposure to light.

  • SPL UNCLASSIFIED SECTION

    Reorder #005554


    Questions?
    (855) 724-3461

    Distributed by:Covetrus North America
    400 Metro Place North
    Dublin, OH 43017
    covetrus.com

    Made in USA

  • Principal Display Panel

    Covetrus Vitamin B12 5000

  • INGREDIENTS AND APPEARANCE
    VITAMIN B12 
    cyanocobalamin injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11695-1230
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    AMMONIUM SULFATE (UNII: SU46BAM238)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-1230-5100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2020
    Labeler - Covetrus North America (603750329)
    Registrant - Sparhawk Laboratories, Inc. (147979082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparhawk Laboratories, Inc.147979082analysis, manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Hebei Huarong Pharmaceutical Co., Ltd.529658734api manufacture