Label: TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet, film coated

  • NDC Code(s): 65841-758-01, 65841-758-05, 65841-758-10
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated September 14, 2020

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  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Tramadol Hydrochloride and Acetaminophen Tablets USP, 37.5 mg/325 mg

    NDC 65841-758-01

    100 Tablets

    Rx only

    labels
  • INGREDIENTS AND APPEARANCE
    TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 
    tramadol hydrochloride and acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-758
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE37.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size15mm
    FlavorImprint Code 334
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-758-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2012
    2NDC:65841-758-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2012
    3NDC:65841-758-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09046010/15/2012
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-758) , MANUFACTURE(65841-758)