Busulfan
NDC Package 14789-013-10

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.

Busulfan is used as a pretreatment for patients who are undergoing stem cell transplant for chronic myelogenous leukemia (CML). Marketed by Nexus Pharmaceuticals Llc, this product is identified by NDC 14789-013 and is authorized under FDA application ANDA207794.

Identification & Billing

NDC Package Code
14789-013-10
Package Description
8 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code
14789-013
11-Digit Billing Format
14789001310

Clinical Specifications

Proprietary Name
Busulfan
Dosage Form
-
Usage Information
Busulfan is used as a pretreatment for patients who are undergoing stem cell transplant for chronic myelogenous leukemia (CML).

Regulatory & Marketing

Labeler Name
Nexus Pharmaceuticals Llc
FDA Application #
ANDA207794
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-15-2023
End Marketing Date
07-21-2024
Listing Expiration
07-21-2024
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 14789-013-10 identifies a specific commercial package of 8 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Busulfan, labeled by Nexus Pharmaceuticals Llc. 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 Nexus Pharmaceuticals Llc on September 15, 2023. The current certification is valid through July 21, 2024.

What are the primary indications for this medication?

Busulfan is used as a pretreatment for patients who are undergoing stem cell transplant for chronic myelogenous leukemia (CML).

How is this Nexus Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14789001310. 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)
14789-013-10
11-Digit CMS (5-4-2)
14789-0013-10

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