Jardiance Tablet, Film Coated
NDC Package 67296-2324-3

11-digit billing NDC: 67296232403
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Jardiance (empagliflozin) tablets is jARDIANCE is indicated:to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. This formulation utilizes a tablet, film coated delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2324 and is authorized under FDA application NDA204629.

Identification & Billing

NDC Package Code
67296-2324-3
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
67296-2324
11-Digit Billing Format
67296232403
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Jardiance
Non-Proprietary Name
Empagliflozin
Substance Name
Empagliflozin
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
EMPAGLIFLOZIN 25 mg/1
Pharmacologic Class
Usage Information
JARDIANCE is indicated:to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.

Regulatory & Marketing

Labeler Name
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
NDA204629
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-01-2014
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67296-2324-3 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Jardiance, a human prescription drug labeled by Redpharm Drug. This tablet, film coated is formulated for oral use and contains empagliflozin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Redpharm Drug on August 01, 2014. The current certification is valid through December 31, 2027.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296232403. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
67296-2324-3
11-Digit CMS (5-4-2)
67296-2324-03

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.