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
40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2023
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DAPAGLIFLOZIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-6933
Application NumberNDA202293
Product Classification
M
Marketing Category
C73594
G
Generic Name
DAPAGLIFLOZIN
Product Specifications
Route of AdministrationORAL
Effective DateAugust 4, 2022
FDA Product Classification
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
DAPAGLIFLOZIN PROPANEDIOLActive
Quantity: 10 mg in 1 1
Code: 887K2391VH
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
DAPAGLIFLOZIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-6932
Application NumberNDA202293
Product Classification
M
Marketing Category
C73594
G
Generic Name
DAPAGLIFLOZIN
Product Specifications
Route of AdministrationORAL
Effective DateAugust 4, 2022
FDA Product Classification
INGREDIENTS (6)
DAPAGLIFLOZIN PROPANEDIOLActive
Quantity: 5 mg in 1 1
Code: 887K2391VH
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT