Label: ALBENDAZOLE tablet, film coated

  • NDC Code(s): 70771-1103-1, 70771-1103-3, 70771-1103-5, 70771-1103-6, view more
    70771-1103-7, 70771-1103-8
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 5, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1103-7

    Albendazole Tablets USP, 200 mg

    28 Tablets

    Rx only

    Albendazole tablets
  • INGREDIENTS AND APPEARANCE
    ALBENDAZOLE 
    albendazole tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALBENDAZOLE (UNII: F4216019LN) (ALBENDAZOLE - UNII:F4216019LN) ALBENDAZOLE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF WHITE) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code 1021
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1103-728 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
    2NDC:70771-1103-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
    3NDC:70771-1103-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
    4NDC:70771-1103-81 in 1 BOTTLE12/17/2018
    42 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:70771-1103-62 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    6NDC:70771-1103-31 in 1 CARTON05/27/2020
    62 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20897912/17/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1103) , MANUFACTURE(70771-1103)