FAMOTIDINE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]

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FAMOTIDINE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]
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NDC 52533-172-12
Set ID 36a915cd-75ae-40b8-b174-026d49ea23d7
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Cantrell Drug Company
Generic Name
Product Class
Product Number
Application Number
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  • PRINCIPAL DISPLAY PANEL

    Label

  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-172
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    MANNITOL (UNII: 3OWL53L36A) 4 mg  in 1 mL
    ASPARTIC ACID (UNII: 30KYC7MIAI) 0.005 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52533-172-1210 mL in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/11/2014
    Labeler - Cantrell Drug Company (035545763)
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