Sitagliptin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
NDC Package 70710-2038-3

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

Package Information

Sitagliptin And Metformin Hydrochloride tablets is sitagliptin 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.Limitations of UseSitagliptin and metformin hydrochloride extended-release tablets are not recommended in patients with type 1 diabetes mellitus.Sitagliptin and metformin hydrochloride extended-release tablets have not been studied in patients with a history of pancreatitis. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-2038 and is authorized under FDA application NDA216778.

Identification & Billing

NDC Package Code
70710-2038-3
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
70710-2038
11-Digit Billing Format
70710203803
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1243827 - SITagliptin 100 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1243827 - 24 HR metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral Tablet
  • RxCUI: 1243827 - metformin hydrochloride 1000 MG / sitagliptin 100 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1243842 - SITagliptin 50 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1243842 - 24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Sitagliptin And Metformin Hydrochloride
Non-Proprietary Name
Sitagliptin And Metformin Hydrochloride
Substance Name
Metformin Hydrochloride; Sitagliptin
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
Sitagliptin 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.Limitations of UseSitagliptin and metformin hydrochloride extended-release tablets are not recommended in patients with type 1 diabetes mellitus.Sitagliptin and metformin hydrochloride extended-release tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin and metformin hydrochloride extended-release tablets [see Warnings and Precautions (5.2)].

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA216778
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
10-31-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70710-2038-3 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Sitagliptin And Metformin Hydrochloride, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, film coated, extended release is formulated for oral use and contains metformin hydrochloride; sitagliptin 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 Zydus Pharmaceuticals Usa Inc. on October 31, 2024. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710203803. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
70710-2038-3
11-Digit CMS (5-4-2)
70710-2038-03

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