Label: EXEMESTANE tablet
- NDC Code(s): 70771-1374-3
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 26, 2022
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INGREDIENTS AND APPEARANCE
EXEMESTANE
exemestane tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1374 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EXEMESTANE (UNII: NY22HMQ4BX) (EXEMESTANE - UNII:NY22HMQ4BX) EXEMESTANE 25 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM CARBONATE (UNII: 0E53J927NA) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) Product Characteristics Color WHITE (WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code 383 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1374-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202602 10/08/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1374) , MANUFACTURE(70771-1374)
