Label: TERIFLUNOMIDE tablet, film coated

  • NDC Code(s): 70771-1010-3, 70771-1010-7, 70771-1010-8, 70771-1011-3, view more
    70771-1011-7, 70771-1011-8
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 12, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1010-3

    Teriflunomide Tablets, 7 mg

    30 Tablets

    Rx only

    7 mg

    NDC 70771-1011-3

    Teriflunomide Tablets, 14 mg

    30 Tablets

    Rx only

    14 mg
  • INGREDIENTS AND APPEARANCE
    TERIFLUNOMIDE 
    teriflunomide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TERIFLUNOMIDE (UNII: 1C058IKG3B) (TERIFLUNOMIDE - UNII:1C058IKG3B) TERIFLUNOMIDE7 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)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code 1114
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1010-330 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2023
    2NDC:70771-1010-82 in 1 CARTON02/14/2023
    2NDC:70771-1010-71 in 1 CARTON
    214 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20966802/14/2023
    TERIFLUNOMIDE 
    teriflunomide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TERIFLUNOMIDE (UNII: 1C058IKG3B) (TERIFLUNOMIDE - UNII:1C058IKG3B) TERIFLUNOMIDE14 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (BLUE TO LIGHT BLUE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 1115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1011-330 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2023
    2NDC:70771-1011-82 in 1 CARTON02/14/2023
    2NDC:70771-1011-71 in 1 CARTON
    214 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20966802/14/2023
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1010, 70771-1011) , MANUFACTURE(70771-1010, 70771-1011)