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 use Initial U.S. Approval: 2007
Approved
Approval ID
e20ab2fe-bc9f-48a3-b15a-e4bc9532c2ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Sigmapharm Laboratories, LLC
DUNS: 556234636
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 Code42794-051
Application NumberANDA208354
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMBRISENTAN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (12)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
AMBRISENTANActive
Quantity: 5 mg in 1 1
Code: HW6NV07QEC
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
AMBRISENTAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-052
Application NumberANDA208354
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMBRISENTAN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMBRISENTANActive
Quantity: 10 mg in 1 1
Code: HW6NV07QEC
Classification: ACTIB