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
39b2a85f-4322-42d4-b420-1b1d52569143
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code0591-2512
Application NumberANDA207110
Product Classification
M
Marketing Category
C73584
G
Generic Name
bosentan
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (12)
BOSENTANActive
Quantity: 125 mg in 1 1
Code: Q326023R30
Classification: ACTIM
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
bosentan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-2511
Application NumberANDA207110
Product Classification
M
Marketing Category
C73584
G
Generic Name
bosentan
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (12)
BOSENTANActive
Quantity: 62.5 mg in 1 1
Code: Q326023R30
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT