Label: VITAMIN B-12 5000 MCG- cyanocobalamin injection
- NDC Code(s): 13985-056-85
- Packager: MWI/Vet One
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 2, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS:
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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 & ADMINISTRATION:
- STORAGE:
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
VITAMIN B-12 5000 MCG
cyanocobalamin injectionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:13985-056 Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13985-056-85 100 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/01/2017 Labeler - MWI/Vet One (019926120) Registrant - Sparhawk Laboratories, Inc. (147979082) Establishment Name Address ID/FEI Business Operations Sparhawk Laboratories, Inc. 147979082 analysis, manufacture Establishment Name Address ID/FEI Business Operations Hebei Huarong Pharmaceutical Co., Ltd. 529658734 api manufacture