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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 useInitial U.S. Approval: 2009

Approved
Approval ID

e286ffd4-c598-47fb-af06-2e15f7e6f99f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 1, 2023

Manufacturers
FDA

Glenmark Pharmaceuticals Inc., USA

DUNS: 130597813

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 Code68462-727
Application NumberANDA205994
Product Classification
M
Marketing Category
C73584
G
Generic Name
SAXAGLIPTIN
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification

INGREDIENTS (15)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
saxagliptin hydrochlorideActive
Quantity: 5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM

SAXAGLIPTIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68462-726
Application NumberANDA205994
Product Classification
M
Marketing Category
C73584
G
Generic Name
SAXAGLIPTIN
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification

INGREDIENTS (15)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
saxagliptin hydrochlorideActive
Quantity: 2.5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM

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SAXAGLIPTIN - FDA Drug Approval Details