MedPath
FDA Approval

Jardiance

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
November 21, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Empagliflozin(25 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Manufacturing Establishments10

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Boehringer Ingelheim Pharma GmbH and Co. KG

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

551147440

Boehringer Ingelheim Promeco, S.A. de C.V.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

812579472

Rottendorf Pharma GmbH

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

315974691

BOEHRINGER INGELHEIM HELLAS SINGLE MEMBER S.A.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

506915691

F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

339689422

Sixarp, LLC

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

016329513

Boehringer Ingelheim España, S.A.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

465561546

Boehringer Ingelheim Promeco S.A de C.V.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

812579472

West-Ward Columbus Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

058839929

Bidachem S.p.a.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc.

429232812

Products2

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

Jardiance

Product Details

NDC Product Code
0597-0153
Application Number
NDA204629
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 21, 2023
Code: HDC1R2M35UClass: ACTIBQuantity: 25 mg in 1 1

Jardiance

Product Details

NDC Product Code
0597-0152
Application Number
NDA204629
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
November 21, 2023
Code: HDC1R2M35UClass: ACTIBQuantity: 10 mg in 1 1
© Copyright 2025. All Rights Reserved by MedPath
Jardiance - FDA Approval | MedPath