Label: DARUNAVIR tablet, film coated
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NDC Code(s):
70771-1745-5,
70771-1745-6,
70771-1745-8,
70771-1746-3, view more70771-1746-5, 70771-1746-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 29, 2024
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INGREDIENTS AND APPEARANCE
DARUNAVIR
darunavir tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1745 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DARUNAVIR (UNII: YO603Y8113) (DARUNAVIR - UNII:YO603Y8113) DARUNAVIR 600 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BROWN Score no score Shape OVAL Size 20mm Flavor Imprint Code 1215 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1745-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2024 2 NDC:70771-1745-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2024 3 NDC:70771-1745-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214085 05/01/2024 DARUNAVIR
darunavir tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1746 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DARUNAVIR (UNII: YO603Y8113) (DARUNAVIR - UNII:YO603Y8113) DARUNAVIR 800 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (beige colored) Score no score Shape OVAL Size 21mm Flavor Imprint Code 1217 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1746-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2024 2 NDC:70771-1746-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2024 3 NDC:70771-1746-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214085 05/01/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1745, 70771-1746) , MANUFACTURE(70771-1745, 70771-1746)
