Melphalan Hydrochloride
NDC Package 10139-321-01

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 inactivated by the FDA.

Melphalan Hydrochloride is for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. Marketed by Generamedix Inc., this product is identified by NDC 10139-321 and is authorized under FDA application ANDA090299.

Identification & Billing

NDC Package Code
10139-321-01
Package Description
1 KIT in 1 CARTON * 10 mL in 1 VIAL (10139-320-10) * 10 mL in 1 VIAL, SINGLE-DOSE (10139-319-10)
Product Code
10139-321
11-Digit Billing Format
10139032101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Melphalan Hydrochloride
Dosage Form
-
Usage Information
Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Regulatory & Marketing

Labeler Name
Generamedix Inc.
FDA Application #
ANDA090299
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-27-2009
Listing Expiration
12-31-2017
Exclude Flag
I
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 10139-321-01 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial (10139-320-10) * 10 ml in 1 vial, single-dose (10139-319-10) of Melphalan Hydrochloride, labeled by Generamedix Inc.. 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 Generamedix Inc. on October 27, 2009. The current certification is valid through December 31, 2017.

How is this Generamedix Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10139032101. 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)
10139-321-01
11-Digit CMS (5-4-2)
10139-0321-01

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