QTERN
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . QTERN® (dapagliflozin and saxagliptin) tablets, for oral useInitial U.S. Approval: 2017
Approved
Approval ID
423c489c-085b-4320-b892-7868ebd6dc6b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2023
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dapagliflozin and saxagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-6770
Application NumberNDA209091
Product Classification
M
Marketing Category
C73594
G
Generic Name
dapagliflozin and saxagliptin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2023
FDA Product Classification
INGREDIENTS (12)
DAPAGLIFLOZINActive
Quantity: 5 mg in 1 1
Code: 1ULL0QJ8UC
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERROUS OXIDEInactive
Code: G7036X8B5H
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SAXAGLIPTIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM
dapagliflozin and saxagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-6780
Application NumberNDA209091
Product Classification
M
Marketing Category
C73594
G
Generic Name
dapagliflozin and saxagliptin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2023
FDA Product Classification
INGREDIENTS (12)
DAPAGLIFLOZINActive
Quantity: 10 mg in 1 1
Code: 1ULL0QJ8UC
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERROUS OXIDEInactive
Code: G7036X8B5H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SAXAGLIPTIN HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM