Label: ANASTROZOLE tablet, coated
- NDC Code(s): 65841-743-06, 65841-743-10
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 3, 2022
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INGREDIENTS AND APPEARANCE
ANASTROZOLE
anastrozole tablet, coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-743 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANASTROZOLE (UNII: 2Z07MYW1AZ) (ANASTROZOLE - UNII:2Z07MYW1AZ) ANASTROZOLE 1 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE (WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code A7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-743-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/27/2010 2 NDC:65841-743-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/27/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078921 06/27/2010 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-743) , MANUFACTURE(65841-743)