Bosentan
These highlights do not include all the information needed to use BOSENTAN TABLETS safely and effectively. See full prescribing information for BOSENTAN TABLETS. BOSENTAN tablets, for oral use Initial U.S. Approval: 2001
Approved
Approval ID
dc117215-2304-41c1-ad3c-31d5e1029657
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bosentan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-874
Application NumberANDA209742
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bosentan
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2019
FDA Product Classification
INGREDIENTS (13)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
BOSENTAN ANHYDROUSActive
Quantity: 125 mg in 1 1
Code: XUL93R30K2
Classification: ACTIB
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Bosentan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-873
Application NumberANDA209742
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bosentan
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2019
FDA Product Classification
INGREDIENTS (13)
BOSENTAN ANHYDROUSActive
Quantity: 62.5 mg in 1 1
Code: XUL93R30K2
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT