Jardiance
These highlights do not include all the information needed to use JARDIANCE safely and effectively. See full prescribing information for JARDIANCE. JARDIANCE (empagliflozin tablets), for oral useInitial U.S. Approval: 2014
Approved
Approval ID
5777b8a8-ada6-4950-8548-43a1de11f075
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 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.
Empagliflozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-0411
Application NumberNDA204629
Product Classification
M
Marketing Category
C73594
G
Generic Name
Empagliflozin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2019
FDA Product Classification
INGREDIENTS (13)
empagliflozinActive
Quantity: 10 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
EMPAGLIFLOZINActive
Quantity: 10 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Empagliflozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-0412
Application NumberNDA204629
Product Classification
M
Marketing Category
C73594
G
Generic Name
Empagliflozin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2019
FDA Product Classification
INGREDIENTS (13)
empagliflozinActive
Quantity: 25 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
EMPAGLIFLOZINActive
Quantity: 25 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT