Label: TRAMADOL HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 65841-754-01, 65841-754-05, 65841-754-10, 65841-754-30
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

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  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Tramadol Hydrochloride Tablets USP, 50 mg

    NDC 65841-754-01 in bottle of 100 tablets

    100 tablets

    Rx only

    Tramadol HCl Tablets
  • INGREDIENTS AND APPEARANCE
    TRAMADOL HYDROCHLORIDE 
    tramadol hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-754
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 319
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-754-3010 in 1 CARTON01/31/2011
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:65841-754-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2011
    3NDC:65841-754-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2011
    4NDC:65841-754-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09040401/31/2011
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - CADILA HEALTHCARE LIMITED (677605858)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-754) , MANUFACTURE(65841-754)
    Establishment
    NameAddressID/FEIBusiness Operations
    CADILA HEALTHCARE LIMITED677605858ANALYSIS(65841-754) , MANUFACTURE(65841-754)