Busulfan
NDC Package 72485-210-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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 Armas Pharmaceuticals Inc., this product is identified by NDC 72485-210 and is authorized under FDA application ANDA210931.

Identification & Billing

NDC Package Code
72485-210-08
Package Description
8 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (72485-210-01)
Product Code
72485-210
11-Digit Billing Format
72485021008
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

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
Armas Pharmaceuticals Inc.
FDA Application #
ANDA210931
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2019
End Marketing Date
05-21-2026
Listing Expiration
05-21-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0594
Source: PDAC
INJECTION, BUSULFAN, 1 MG
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 72485-210-08 identifies a specific commercial package of 8 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (72485-210-01) of Busulfan, labeled by Armas Pharmaceuticals 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 Armas Pharmaceuticals Inc. on June 01, 2019. The current certification is valid through May 21, 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 Armas Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72485021008. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
72485-210-08
11-Digit CMS (5-4-2)
72485-0210-08

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