Label: DUTASTERIDE capsule, liquid filled
- NDC Code(s): 70771-1347-3, 70771-1347-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 11, 2024
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INGREDIENTS AND APPEARANCE
DUTASTERIDE
dutasteride capsule, liquid filledProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1347 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I) DUTASTERIDE 0.5 mg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALCOHOL (UNII: 3K9958V90M) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) AMMONIA (UNII: 5138Q19F1X) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (OPAQUE-WHITE) Score no score Shape CAPSULE (Oblong Shaped) Size 20mm Flavor Imprint Code 641 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1347-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2018 2 NDC:70771-1347-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204373 05/16/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1347) , MANUFACTURE(70771-1347)
