BICALUTAMIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-613-06 in bottle of 30 tablets

Bicalutamide Tablets USP, 50 mg

Rx only

30 tablets

BICALUTAMIDE
bicalutamide tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP)	BICALUTAMIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-613-06	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2009	12/16/2022
2	NDC:65841-613-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2009	12/16/2022
3	NDC:65841-613-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2009	12/16/2022
4	NDC:65841-613-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2009	12/16/2022
5	NDC:65841-613-30	10 in 1 CARTON	07/06/2009	12/16/2022
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079089	07/06/2009	12/16/2022

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-613) , MANUFACTURE(65841-613)

Revised: 12/2022

Document Id: 2b9f302e-27a7-4b8c-a678-dfe131ae0b90

Set id: 8e26fbf0-511c-44d9-b484-372d7b50b55e

Version: 8

Effective Time: 20221216

Zydus Lifesciences Limited