Label: MODAFINIL tablet
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NDC Code(s):
70771-1051-1,
70771-1051-3,
70771-1051-9,
70771-1052-1, view more70771-1052-3, 70771-1052-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CIV
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 4, 2023
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INGREDIENTS AND APPEARANCE
MODAFINIL
modafinil tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1051 Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MODAFINIL (UNII: R3UK8X3U3D) (MODAFINIL - UNII:R3UK8X3U3D) MODAFINIL 100 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (OFF-WHITE) Score no score Shape CAPSULE (CAPSULE) Size 13mm Flavor Imprint Code 1072 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1051-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/04/2018 2 NDC:70771-1051-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/04/2018 3 NDC:70771-1051-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/04/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209966 01/04/2018 MODAFINIL
modafinil tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1052 Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MODAFINIL (UNII: R3UK8X3U3D) (MODAFINIL - UNII:R3UK8X3U3D) MODAFINIL 200 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (OFF-WHITE) Score 2 pieces Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code 10;73 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1052-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/04/2018 2 NDC:70771-1052-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/04/2018 3 NDC:70771-1052-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/04/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209966 01/04/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1051, 70771-1052) , MANUFACTURE(70771-1051, 70771-1052)
