Label: MODAFINIL tablet

  • NDC Code(s): 70771-1051-1, 70771-1051-3, 70771-1051-9, 70771-1052-1, view more
    70771-1052-3, 70771-1052-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 1, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1051-3

    Modafinil Tablets USP, 100 mg

    30 Tablets

    Rx only

    Modafinil Tablets USP, 100mg and 200mg

    NDC 70771-1052-3

    Modafinil Tablets USP, 200 mg

    30 Tablets

    Rx only

    Modafinil Tablets USP, 100mg and 200mg
  • INGREDIENTS AND APPEARANCE
    MODAFINIL 
    modafinil tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1051
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MODAFINIL (UNII: R3UK8X3U3D) (MODAFINIL - UNII:R3UK8X3U3D) MODAFINIL100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size13mm
    FlavorImprint Code 1072
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1051-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    2NDC:70771-1051-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    3NDC:70771-1051-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20996601/04/2018
    MODAFINIL 
    modafinil tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1052
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MODAFINIL (UNII: R3UK8X3U3D) (MODAFINIL - UNII:R3UK8X3U3D) MODAFINIL200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (OFF-WHITE) Score2 pieces
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code 10;73
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1052-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    2NDC:70771-1052-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    3NDC:70771-1052-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20996601/04/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1051, 70771-1052) , MANUFACTURE(70771-1051, 70771-1052)