Regranex
NDC Package 0045-0810-15

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.

Regranex is a medication used to treat certain foot/leg ulcers in people with diabetes. Marketed by Ortho-mcneil-janssen Pharmaceuticals, Inc., this product is identified by NDC 0045-0810 and is authorized under FDA application BLA103691.

Identification & Billing

NDC Package Code
0045-0810-15
Package Description
1 TUBE in 1 CARTON / 15 g in 1 TUBE
Product Code
0045-0810
11-Digit Billing Format
00045081015
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
15 GM

Clinical Specifications

Proprietary Name
Regranex
Dosage Form
-
Usage Information
This medication is used to treat certain foot/leg ulcers in people with diabetes. It is used along with good foot/leg care (e.g., keeping pressure off the wound) to help the ulcer heal completely. Becaplermin works by attracting certain natural substances to the ulcer that help wound healing.

Regulatory & Marketing

Labeler Name
Ortho-mcneil-janssen Pharmaceuticals, Inc.
FDA Application #
BLA103691
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-01-1998
End Marketing Date
01-31-2013
Listing Expiration
01-31-2013
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 0045-0810-15 identifies a specific commercial package of 1 tube in 1 carton / 15 g in 1 tube of Regranex, labeled by Ortho-mcneil-janssen Pharmaceuticals, Inc.. This product is billed per "GM" gram and contains an estimated amount of 15 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 Ortho-mcneil-janssen Pharmaceuticals, Inc. on February 01, 1998. The current certification is valid through January 31, 2013.

What are the primary indications for this medication?

This medication is used to treat certain foot/leg ulcers in people with diabetes. It is used along with good foot/leg care (e.g., keeping pressure off the wound) to help the ulcer heal completely. Becaplermin works by attracting certain natural substances to the ulcer that help wound healing.

How is this Ortho-mcneil-janssen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00045081015. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 15 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)
0045-0810-15
11-Digit CMS (5-4-2)
00045-0810-15

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