HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]

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HYDROMORPHONE HCL INJECTION, SOLUTION [CANTRELL DRUG COMPANY]
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NDC 52533-145-05
Set ID c57b413c-18e8-47b7-aff0-879e6d39693d
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Cantrell Drug Company
Generic Name
Product Class
Product Number
Application Number
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  • PRINCIPAL DISPLAY PANEL

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  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    HYDROMORPHONE HCL 
    hydromorphone hcl injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-145
    Route of AdministrationINTRAVENOUSDEA ScheduleCII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROMORPHONE HYDROCHLORIDE (UNII: L960UP2KRW) (HYDROMORPHONE - UNII:Q812464R06) HYDROMORPHONE HYDROCHLORIDE0.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X) 9 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:52533-145-0530 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/13/2014
    Labeler - Cantrell Drug Company (035545763)
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