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Synjardy

These highlights do not include all the information needed to use SYNJARDY and SYNJARDY XR safely and effectively. See full prescribing information for SYNJARDY and SYNJARDY XR. SYNJARDY (empagliflozin and metformin hydrochloride tablets), for oral use SYNJARDY XR (empagliflozin and metformin hydrochloride extended-release tablets), for oral use Initial U.S. Approval: 2015

Approved
Approval ID

0fdd0255-0055-65f3-b2c0-db8fbb87beae

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 13, 2023

Manufacturers
FDA

Boehringer Ingelheim Pharmaceuticals, Inc.

DUNS: 603175944

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

empagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0597-0168
Application NumberNDA206111
Product Classification
M
Marketing Category
C73594
G
Generic Name
empagliflozin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification

INGREDIENTS (2)

EMPAGLIFLOZINActive
Quantity: 12.5 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB

empagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0597-0175
Application NumberNDA206111
Product Classification
M
Marketing Category
C73594
G
Generic Name
empagliflozin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification

INGREDIENTS (2)

METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
EMPAGLIFLOZINActive
Quantity: 5 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB

empagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0597-0159
Application NumberNDA206111
Product Classification
M
Marketing Category
C73594
G
Generic Name
empagliflozin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification

INGREDIENTS (2)

METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
EMPAGLIFLOZINActive
Quantity: 5 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB

empagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0597-0180
Application NumberNDA206111
Product Classification
M
Marketing Category
C73594
G
Generic Name
empagliflozin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification

INGREDIENTS (2)

METFORMIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
EMPAGLIFLOZINActive
Quantity: 12.5 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB

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Synjardy - FDA Drug Approval Details