Label: BICALUTAMIDE tablet, film coated
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NDC Code(s):
65841-613-01,
65841-613-05,
65841-613-06,
65841-613-10, view more65841-613-30
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2022
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INGREDIENTS AND APPEARANCE
BICALUTAMIDE
bicalutamide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-613 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP) BICALUTAMIDE 50 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF- WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZE;57 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-613-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2009 2 NDC:65841-613-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2009 3 NDC:65841-613-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2009 4 NDC:65841-613-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2009 5 NDC:65841-613-30 10 in 1 CARTON 07/06/2009 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079089 07/06/2009 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-613) , MANUFACTURE(65841-613)
