DAPAGLIFLOZIN
These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral useInitial U.S. Approval: 2014
Approved
Approval ID
3aba33aa-f8c6-4b10-85c8-dfa14578d07c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2023
Manufacturers
FDA
PRASCO, LLC
DUNS: 065969375
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 Code66993-456
Application NumberNDA202293
Product Classification
M
Marketing Category
C73605
G
Generic Name
DAPAGLIFLOZIN
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (6)
DAPAGLIFLOZIN PROPANEDIOLActive
Quantity: 5 mg in 1 1
Code: 887K2391VH
Classification: ACTIM
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
DAPAGLIFLOZIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-457
Application NumberNDA202293
Product Classification
M
Marketing Category
C73605
G
Generic Name
DAPAGLIFLOZIN
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (6)
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
DAPAGLIFLOZIN PROPANEDIOLActive
Quantity: 10 mg in 1 1
Code: 887K2391VH
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT