Trijardy Xr Tablet, Extended Release
NDC Package 0597-0385-86

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

Package Information

Trijardy Xr (empagliflozin, linagliptin, metformin hydrochloride) tablets is tRIJARDY XR is a combination of empagliflozin, linagliptin, and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14.2)]. This formulation utilizes a tablet, extended release delivery system. Marketed by Boehringer Ingelheim Pharmaceuticals, Inc., this product is identified by NDC 0597-0385 and is authorized under FDA application NDA212614.

Identification & Billing

NDC Package Code
0597-0385-86
Package Description
180 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
0597-0385
11-Digit Billing Format
00597038586
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
180 EA
RxNorm Crosswalk
  • RxCUI: 2359279 - empagliflozin 10 MG / linagliptin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 2359279 - 24 HR empagliflozin 10 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
  • RxCUI: 2359279 - 24 HR empagliflozin 10 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 2359285 - Trijardy XR 10 MG / 5 MG / 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 2359285 - 24 HR empagliflozin 10 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]

Clinical Specifications

Proprietary Name
Trijardy Xr
Non-Proprietary Name
Empagliflozin, Linagliptin, Metformin Hydrochloride
Substance Name
Empagliflozin; Linagliptin; Metformin Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
TRIJARDY XR is a combination of empagliflozin, linagliptin, and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14.2)].

Regulatory & Marketing

Labeler Name
Boehringer Ingelheim Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA212614
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-23-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0597-0385). Click a package code to view its specific billing and regulatory data.

0597-0385-77
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
0597-0385-88
1 BOTTLE in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE

* 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 0597-0385-86 identifies a specific commercial package of 180 tablet, extended release in 1 bottle of Trijardy Xr, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. This tablet, extended release is formulated for oral use and contains empagliflozin; linagliptin; metformin hydrochloride 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 Boehringer Ingelheim Pharmaceuticals, Inc. on April 23, 2020. The current certification is valid through December 31, 2027.

How is this Boehringer Ingelheim Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00597038586. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 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 (4-4-2)
0597-0385-86
11-Digit CMS (5-4-2)
00597-0385-86

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