FARXIGA
These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA (dapagliflozin) tablets, for oral useInitial U.S. Approval: 2014
Approved
Approval ID
72ad22ae-efe6-4cd6-a302-98aaee423d69
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
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
PRODUCT DETAILS
NDC Product Code0310-6205
Application NumberNDA202293
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 15, 2024
Generic NameDAPAGLIFLOZIN
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
DAPAGLIFLOZIN PROPANEDIOLActive
Quantity: 5 mg in 1 1
Code: 887K2391VH
Classification: ACTIM
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
DAPAGLIFLOZIN
PRODUCT DETAILS
NDC Product Code0310-6210
Application NumberNDA202293
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 15, 2024
Generic NameDAPAGLIFLOZIN
INGREDIENTS (6)
DAPAGLIFLOZIN PROPANEDIOLActive
Quantity: 10 mg in 1 1
Code: 887K2391VH
Classification: ACTIM
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT