Saxagliptin
These highlights do not include all the information needed to use SAXAGLIPTIN TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN TABLETS. SAXAGLIPTIN tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
6e390c1b-a539-48f4-af32-24723121afb8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2022
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.
Saxagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-059
Application NumberANDA205941
Product Classification
M
Marketing Category
C73584
G
Generic Name
Saxagliptin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2023
FDA Product Classification
INGREDIENTS (17)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SAXAGLIPTIN HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM
Saxagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-060
Application NumberANDA205941
Product Classification
M
Marketing Category
C73584
G
Generic Name
Saxagliptin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2023
FDA Product Classification
INGREDIENTS (17)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SAXAGLIPTIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM