Busulfan Injection, Solution
NDC Package 71288-116-11

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

Busulfan injection is busulfan is used as a pretreatment for patients who are undergoing stem cell transplant for chronic myelogenous leukemia (CML). This formulation utilizes a injection, solution delivery system. Marketed by Meitheal Pharmaceuticals Inc., this product is identified by NDC 71288-116 and is authorized under FDA application ANDA212127.

Identification & Billing

NDC Package Code
71288-116-11
Package Description
8 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (71288-116-10)
Product Code
71288-116
11-Digit Billing Format
71288011611
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Busulfan
Non-Proprietary Name
Busulfan
Substance Name
Busulfan
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
BUSULFAN 6 mg/mL
Pharmacologic Class
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
Meitheal Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212127
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-23-2020
Listing Expiration
12-31-2026
Exclude Flag
N
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 71288-116-11 identifies a specific commercial package of 8 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (71288-116-10) of Busulfan, a human prescription drug labeled by Meitheal Pharmaceuticals Inc.. This injection, solution is formulated for intravenous 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 Meitheal Pharmaceuticals Inc. on October 23, 2020. 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 Meitheal Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71288011611. 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)
71288-116-11
11-Digit CMS (5-4-2)
71288-0116-11

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