Label: FELBAMATE tablet

  • NDC Code(s): 70771-1077-1, 70771-1077-3, 70771-1077-4, 70771-1077-5, view more
    70771-1077-9, 70771-1078-1, 70771-1078-3, 70771-1078-4, 70771-1078-5, 70771-1078-8, 70771-1078-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated October 4, 2023

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  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1077-1

    Felbamate tablets USP, 400 mg

    100 Tablets

    Rx only

    labels

    NDC 70771-1078-1

    Felbamate tablets USP, 600 mg

    100 Tablets

    Rx only

    labels
  • INGREDIENTS AND APPEARANCE
    FELBAMATE 
    felbamate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1077
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8) FELBAMATE400 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (OFF-WHITE TO PALE YELLOW COLOR) Score2 pieces
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code 10;53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1077-330 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
    2NDC:70771-1077-990 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
    3NDC:70771-1077-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
    4NDC:70771-1077-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
    5NDC:70771-1077-410 in 1 CARTON08/15/2017
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20897008/15/2017
    FELBAMATE 
    felbamate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1078
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8) FELBAMATE600 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (LIGHT PINK TO PINK) Score2 pieces
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code 10;54
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1078-330 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
    2NDC:70771-1078-990 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
    3NDC:70771-1078-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
    4NDC:70771-1078-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
    5NDC:70771-1078-410 in 1 CARTON08/15/2017
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:70771-1078-8180 in 1 BOTTLE; Type 0: Not a Combination Product08/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20897008/15/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1077, 70771-1078) , MANUFACTURE(70771-1077, 70771-1078)
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