Prandin
NDC Package 60846-882-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Prandin is repaglinide is used alone or with other medications to control high blood sugar along with a proper diet and exercise program. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 60846-882 and is authorized under FDA application ANDA077571.

Identification & Billing

NDC Package Code
60846-882-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
60846-882
11-Digit Billing Format
60846088201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Prandin
Dosage Form
-
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
Amneal Pharmaceuticals Llc
FDA Application #
ANDA077571
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-02-2017
End Marketing Date
08-01-2022
Listing Expiration
08-01-2022
Exclude Flag
D
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 60846-882-01 identifies a specific commercial package of 100 tablet in 1 bottle of Prandin, labeled by Amneal Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Amneal Pharmaceuticals Llc on February 02, 2017. The current certification is valid through August 01, 2022.

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 Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60846088201. 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)
60846-882-01
11-Digit CMS (5-4-2)
60846-0882-01

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