Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bosentan
Product Details
NDC Product Code
0591-2512Application Number
ANDA207110Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 31, 2023BosentanActive
Code: Q326023R30Class: ACTIMQuantity: 125 mg in 1 1
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SRClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
bosentan
Product Details
NDC Product Code
0591-2511Application Number
ANDA207110Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 31, 2023BosentanActive
Code: Q326023R30Class: ACTIMQuantity: 62.5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62Class: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SRClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT