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
65162-874Application Number
ANDA209742Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 18, 2019FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
BosentanActive
Code: XUL93R30K2Class: ACTIBQuantity: 125 mg in 1 1
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SRClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Bosentan
Product Details
NDC Product Code
65162-873Application Number
ANDA209742Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 18, 2019BosentanActive
Code: XUL93R30K2Class: ACTIBQuantity: 62.5 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SRClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT