Label: FINASTERIDE tablet, film coated
- NDC Code(s): 70771-1152-0, 70771-1152-1, 70771-1152-3, 70771-1152-4
- 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
FINASTERIDE
finasteride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1152 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G) FINASTERIDE 5 mg Inactive Ingredients Ingredient Name Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SHELLAC (UNII: 46N107B71O) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSES (UNII: 3NXW29V3WO) Product Characteristics Color BLUE (blue) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZE;56 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1152-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 2 NDC:70771-1152-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 3 NDC:70771-1152-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 4 NDC:70771-1152-4 10 in 1 CARTON 12/05/2017 4 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 ANDA078900 12/05/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1152) , MANUFACTURE(70771-1152)
