Ambrisentan
These highlights do not include all the information needed to use AMBRISENTAN TABLETS safely and effectively. See full prescribing information for AMBRISENTAN TABLETS. AMBRISENTAN tablets, for oral useInitial U.S. Approval: 2007
Approved
Approval ID
37af3191-0ed3-4783-8747-065f1462f2d2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 16, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ambrisentan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1179
Application NumberANDA210058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ambrisentan
Product Specifications
Route of AdministrationORAL
Effective DateMarch 16, 2023
FDA Product Classification
INGREDIENTS (13)
AMBRISENTANActive
Quantity: 5 mg in 1 1
Code: HW6NV07QEC
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
Ambrisentan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1180
Application NumberANDA210058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ambrisentan
Product Specifications
Route of AdministrationORAL
Effective DateMarch 16, 2023
FDA Product Classification
INGREDIENTS (11)
AMBRISENTANActive
Quantity: 10 mg in 1 1
Code: HW6NV07QEC
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT