Label: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE capsule
- NDC Code(s): 70771-1356-3, 70771-1356-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 21, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride and tamsulosin hydrochloride capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1356 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I) DUTASTERIDE 0.5 mg TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I) TAMSULOSIN HYDROCHLORIDE 0.4 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARRAGEENAN (UNII: 5C69YCD2YJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) HYPROMELLOSES (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CHLORIDE (UNII: 660YQ98I10) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SHELLAC (UNII: 46N107B71O) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color YELLOW (OPAQUE YELLOW CAP) , WHITE (OPAQUE WHITE BODY) Score no score Shape CAPSULE (CAPSULE) Size 23mm Flavor Imprint Code 640 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1356-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2018 2 NDC:70771-1356-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207769 06/04/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1356) , MANUFACTURE(70771-1356)
