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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

8006ba29-ee3a-f852-a9bb-c8ec9b41cf66

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 31, 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, metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0597-0290
Application NumberNDA208658
Product Classification
M
Marketing Category
C73594
G
Generic Name
empagliflozin, metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification

INGREDIENTS (2)

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

empagliflozin, metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0597-0280
Application NumberNDA208658
Product Classification
M
Marketing Category
C73594
G
Generic Name
empagliflozin, metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification

INGREDIENTS (2)

METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
EMPAGLIFLOZINActive
Quantity: 10 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB

empagliflozin, metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0597-0295
Application NumberNDA208658
Product Classification
M
Marketing Category
C73594
G
Generic Name
empagliflozin, metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification

INGREDIENTS (2)

EMPAGLIFLOZINActive
Quantity: 25 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB

empagliflozin, metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0597-0300
Application NumberNDA208658
Product Classification
M
Marketing Category
C73594
G
Generic Name
empagliflozin, metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 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

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