Busulfan Powder
NDC Package 48957-0010-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Busulfan powders is busulfan is used as a pretreatment for patients who are undergoing stem cell transplant for chronic myelogenous leukemia (CML). This formulation utilizes a powder delivery system. Marketed by Ppl Pharma Solutions Riverview Llc, this product is identified by NDC 48957-0010.

Identification & Billing

NDC Package Code
48957-0010-1
Package Description
.5 kg in 1 BOTTLE
Product Code
48957-0010
11-Digit Billing Format
48957001001

Clinical Specifications

Proprietary Name
Busulfan
Non-Proprietary Name
Busulfan
Substance Name
Busulfan
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
BUSULFAN 1 kg/kg
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
Ppl Pharma Solutions Riverview Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-04-1999
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 48957-0010-1 identifies a specific commercial package of .5 kg in 1 bottle of Busulfan (UNFINISHED drug), a bulk ingredient labeled by Ppl Pharma Solutions Riverview Llc. This powder is formulated for use and contains busulfan 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 Ppl Pharma Solutions Riverview Llc on February 04, 1999. The current certification is valid through December 31, 2026.

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 Ppl Pharma Solutions Riverview Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48957001001. 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 (5-4-1)
48957-0010-1
11-Digit CMS (5-4-2)
48957-0010-01

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