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
f3ea58bb-0002-4a5d-9213-7e9066e3dc9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code65862-825
Application NumberANDA205972
Product Classification
M
Marketing Category
C73584
G
Generic Name
Saxagliptin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (16)
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT
HYDROXYPROPYL CELLULOSE (45000 WAMW)Inactive
Code: 8VAB711C5E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 301Inactive
Code: W7YXH6D4BD
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
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 Code65862-826
Application NumberANDA205972
Product Classification
M
Marketing Category
C73584
G
Generic Name
Saxagliptin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (16)
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
HYDROXYPROPYL CELLULOSE (45000 WAMW)Inactive
Code: 8VAB711C5E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
MICROCRYSTALLINE CELLULOSE 301Inactive
Code: W7YXH6D4BD
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SAXAGLIPTIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM