Glyburide And Metformin Hydrochloride Tablet, Film Coated
NDC Package 57237-024-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Glyburide And Metformin Hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This formulation utilizes a tablet, film coated delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 57237-024 and is authorized under FDA application ANDA077870.

Identification & Billing

NDC Package Code
57237-024-05
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
11-Digit Billing Format
57237002405
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk
  • RxCUI: 861743 - glyBURIDE 1.25 MG / metFORMIN HCl 250 MG Oral Tablet
  • RxCUI: 861743 - glyburide 1.25 MG / metformin hydrochloride 250 MG Oral Tablet
  • RxCUI: 861748 - glyBURIDE 2.5 MG / metFORMIN HCl 500 MG Oral Tablet
  • RxCUI: 861748 - glyburide 2.5 MG / metformin hydrochloride 500 MG Oral Tablet
  • RxCUI: 861753 - glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Glyburide And Metformin Hydrochloride
Non-Proprietary Name
Glyburide And Metformin Hydrochloride
Substance Name
Glyburide; 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.
Usage Information
Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA077870
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-14-2007
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 (57237-024). Click a package code to view its specific billing and regulatory data.

100 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 57237-024-05 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Glyburide And Metformin Hydrochloride, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This tablet, film coated is formulated for oral use and contains glyburide; 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 Rising Pharma Holdings, Inc. on November 14, 2007. The current certification is valid through December 31, 2026.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57237002405. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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 (5-3-2)
57237-024-05
11-Digit CMS (5-4-2)
57237-0024-05

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