Label: BOSENTAN tablet
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NDC Code(s):
70771-1017-1,
70771-1017-2,
70771-1017-4,
70771-1017-5, view more70771-1017-6, 70771-1017-8, 70771-1018-1, 70771-1018-2, 70771-1018-4, 70771-1018-5, 70771-1018-6, 70771-1018-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 20, 2023
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INGREDIENTS AND APPEARANCE
BOSENTAN
bosentan tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1017 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOSENTAN (UNII: Q326023R30) (BOSENTAN ANHYDROUS - UNII:XUL93R30K2) BOSENTAN ANHYDROUS 62.5 mg Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color PINK (LIGHT PINK) Score no score Shape ROUND (BICONVEX) Size 7mm Flavor Imprint Code 446 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1017-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 2 NDC:70771-1017-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 3 NDC:70771-1017-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 4 NDC:70771-1017-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 5 NDC:70771-1017-4 10 in 1 CARTON 05/01/2019 5 NDC:70771-1017-2 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 ANDA207760 05/01/2019 BOSENTAN
bosentan tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1018 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOSENTAN (UNII: Q326023R30) (BOSENTAN ANHYDROUS - UNII:XUL93R30K2) BOSENTAN ANHYDROUS 125 mg Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color PINK (LIGHT PINK) Score no score Shape OVAL (BICONVEX) Size 11mm Flavor Imprint Code 447 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1018-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 2 NDC:70771-1018-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 3 NDC:70771-1018-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 4 NDC:70771-1018-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 5 NDC:70771-1018-4 10 in 1 CARTON 05/01/2019 5 NDC:70771-1018-2 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 ANDA207760 05/01/2019 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1017, 70771-1018) , MANUFACTURE(70771-1017, 70771-1018)
