Label: THIAMINE HYDROCHLORIDE injection

  • NDC Code(s): 59051-9083-5
  • Packager: Neogen Corporation - Nandino
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 12, 2023

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  • Indications:

    For use as a supplemental source of thiamine in dogs, cats, and horses.

  • Each mL Contains:

    Thiamine Hydrochloride..........................500 mg

    Disodium Edetate..............................0.01% w/v

    Benzyle Alcohol (as preservative)..........1.5% v/v

    Water for Injection......................................q.s.

    pH adjusted with Hydrochloric acid or Sodium Hydroxide

  • Dosage and Administration:

    For intravenous or intramuscular use as determined by the veterinarian.

  • Warning:

    Anaphylactogenesis to parental thiamine has occurred. Administer slowly and with caution in doses over 0.10 mL (50mg)

  • STORAGE AND HANDLING

    Store at controlled temperatures between 15° and 30°C (59° - 86°F). 

  • SPL UNCLASSIFIED SECTION

    Manufactured by Sparhawk Laboratories, Lenexa, KS 66215

    for Neogen® Corporation, Lexington, KY 40511 • 859-254-1221

  • Principal Display Panel

    THIAMINE HYDROCHLORIDE

    500 mg/mL

    Sterile Solution

    For use in dogs, cats and horses

    Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian

    FOR ANIMAL USE ONLY

    KEEP OUT OF THE REACH OF CHILDREN

    Net Content:100 mL

    Thiamine Hydrochloride

    Thiamine Hydrochloride

    Thiamine Hydrochloride

  • INGREDIENTS AND APPEARANCE
    THIAMINE HYDROCHLORIDE 
    thiamine hydrochloride injection
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:59051-9083
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE500 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K) .1 mg  in 1 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) .015 mL  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59051-9083-5100 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2000
    Labeler - Neogen Corporation - Nandino (042125879)
    Registrant - Sparhawk Laboratories, Inc. (147979082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sparhawk Laboratories, Inc.147979082analysis, manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangxi Tianxin Pharmaceutical Co., Ltd.527410270api manufacture