Jardiance Tablet, Film Coated
NDC Package 55154-0412-8

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Jardiance (empagliflozin) tablets is empagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. This formulation utilizes a tablet, film coated delivery system. Marketed by Cardinal Health 107, Llc, this product is identified by NDC 55154-0412 and is authorized under FDA application NDA204629.

Identification & Billing

NDC Package Code
55154-0412-8
Package Description
990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
55154-0412
11-Digit Billing Format
55154041208
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
990 EA
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
Empagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Empagliflozin is also used in patients with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Empagliflozin works by increasing the removal of sugar by your kidneys.

Regulatory & Marketing

Labeler Name
Cardinal Health 107, Llc
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 55154-0412-8 identifies a specific commercial package of 990 tablet, film coated in 1 bottle, plastic of Jardiance, a human prescription drug labeled by Cardinal Health 107, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 990 billable units per package. 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 Cardinal Health 107, Llc on August 01, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Empagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Empagliflozin is also used in patients with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Empagliflozin works by increasing the removal of sugar by your kidneys.

How is this Cardinal Health 107, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154041208. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 990 total billable units per package. 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)
55154-0412-8
11-Digit CMS (5-4-2)
55154-0412-08

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