Linagliptin And Metformin Hydrochloride Tablet, Film Coated
NDC Package 72205-409-01

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

Linagliptin And Metformin Hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of Use Linagliptin and metformin hydrochloride tablets are not recommended in patients with type 1 diabetes mellitus. This formulation utilizes a tablet, film coated delivery system. Marketed by Novadoz Pharmaceuticals Llc, this product is identified by NDC 72205-409 and is authorized under FDA application ANDA208459.

Identification & Billing

NDC Package Code
72205-409-01
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
72205-409
11-Digit Billing Format
72205040901
RxNorm Crosswalk
  • RxCUI: 1243020 - linagliptin 2.5 MG / metFORMIN HCl 1000 MG Oral Tablet
  • RxCUI: 1243020 - linagliptin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet
  • RxCUI: 1243027 - linagliptin 2.5 MG / metFORMIN HCl 500 MG Oral Tablet
  • RxCUI: 1243027 - linagliptin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet
  • RxCUI: 1243034 - linagliptin 2.5 MG / metFORMIN HCl 850 MG Oral Tablet

Clinical Specifications

Proprietary Name
Linagliptin And Metformin Hydrochloride
Non-Proprietary Name
Linagliptin And Metformin Hydrochloride
Substance Name
Linagliptin; Metformin Hydrochloride
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)
Pharmacologic Class
Usage Information
Linagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of Use Linagliptin and metformin hydrochloride tablets are not recommended in patients with type 1 diabetes mellitus. Linagliptin and metformin hydrochloride tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using linagliptin and metformin hydrochloride tablets [see Warnings and Precautions (5.2)].

Regulatory & Marketing

Labeler Name
Novadoz Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA208459
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-03-2025
Listing Expiration
12-31-2026
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 (72205-409). Click a package code to view its specific billing and regulatory data.

72205-409-02
180 TABLET, FILM COATED 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 72205-409-01 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Linagliptin And Metformin Hydrochloride, a human prescription drug labeled by Novadoz Pharmaceuticals Llc. This tablet, film coated is formulated for oral use and contains 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 Novadoz Pharmaceuticals Llc on November 03, 2025. The current certification is valid through December 31, 2026.

How is this Novadoz Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72205040901. 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 (5-3-2)
72205-409-01
11-Digit CMS (5-4-2)
72205-0409-01

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