Saxagliptin And Metformin Tablet, Film Coated, Extended Release
NDC Package 0378-8176-91

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

Package Information

Saxagliptin And Metformin tablets is saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate [see Clinical Studies (14)]. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-8176 and is authorized under FDA application ANDA205981.

Identification & Billing

NDC Package Code
0378-8176-91
Package Description
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
0378-8176
11-Digit Billing Format
00378817691
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 1043563 - sAXagliptin 2.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1043563 - 24 HR metformin hydrochloride 1000 MG / saxagliptin 2.5 MG Extended Release Oral Tablet
  • RxCUI: 1043563 - metformin hydrochloride 1000 MG / saxagliptin (as saxagliptin hydrochloride) 2.5 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1043570 - sAXagliptin 5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1043570 - 24 HR metformin hydrochloride 1000 MG / saxagliptin 5 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Saxagliptin And Metformin
Non-Proprietary Name
Saxagliptin And Metformin
Substance Name
Metformin Hydrochloride; Saxagliptin Hydrochloride Dihydrate
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205981
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-08-2023
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 0378-8176-91 identifies a specific commercial package of 60 tablet, film coated, extended release in 1 bottle, plastic of Saxagliptin And Metformin, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This tablet, film coated, extended release is formulated for oral use and contains metformin hydrochloride; saxagliptin hydrochloride dihydrate 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 Mylan Pharmaceuticals Inc. on August 08, 2023. The current certification is valid through December 31, 2027.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378817691. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
0378-8176-91
11-Digit CMS (5-4-2)
00378-8176-91

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