Bosentan
BOSENTAN TABLETS
Approved
Approval ID
02892f47-0d59-4254-9ee7-d524278fdd79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1017
Application NumberANDA207760
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bosentan
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 20, 2023
FDA Product Classification
INGREDIENTS (13)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
BOSENTANActive
Quantity: 62.5 mg in 1 1
Code: Q326023R30
Classification: ACTIM
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Bosentan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1018
Application NumberANDA207760
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bosentan
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 20, 2023
FDA Product Classification
INGREDIENTS (13)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
BOSENTANActive
Quantity: 125 mg in 1 1
Code: Q326023R30
Classification: ACTIM
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT