Repaglinide Tablet
NDC Package 57237-159-01

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

Repaglinide tablets is repaglinide is used alone or with other medications to control high blood sugar along with a proper diet and exercise program. This formulation utilizes a tablet delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 57237-159 and is authorized under FDA application ANDA203820.

Identification & Billing

NDC Package Code
57237-159-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
57237-159
11-Digit Billing Format
57237015901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Repaglinide
Non-Proprietary Name
Repaglinide
Substance Name
Repaglinide
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
REPAGLINIDE 2 mg/1
Pharmacologic Class
Usage Information
Repaglinide is used alone or with other medications to control high blood sugar along with a proper diet and exercise program. It is used in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. It works by stimulating the body to produce more insulin. Insulin is a natural substance that allows the body to properly use sugar from the diet.

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203820
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-22-2014
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 (57237-159). Click a package code to view its specific billing and regulatory data.

57237-159-05
500 TABLET 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 57237-159-01 identifies a specific commercial package of 100 tablet in 1 bottle of Repaglinide, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This tablet is formulated for oral use and contains repaglinide 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 January 22, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Repaglinide is used alone or with other medications to control high blood sugar along with a proper diet and exercise program. It is used in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. It works by stimulating the body to produce more insulin. Insulin is a natural substance that allows the body to properly use sugar from the diet.

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: 57237015901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
57237-159-01
11-Digit CMS (5-4-2)
57237-0159-01

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