Myleran Tablet, Film Coated
NDC Package 80725-620-25

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

Myleran (busulfan) tablets is busulfan is used to treat chronic myelogenous leukemia (CML). This formulation utilizes a tablet, film coated delivery system. Marketed by Waylis Therapeutics Llc, this product is identified by NDC 80725-620 and is authorized under FDA application NDA009386.

Identification & Billing

NDC Package Code
80725-620-25
Package Description
25 TABLET, FILM COATED in 1 BOTTLE
Product Code
80725-620
11-Digit Billing Format
80725062025
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
25 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Myleran
Non-Proprietary Name
Busulfan
Substance Name
Busulfan
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BUSULFAN 2 mg/1
Pharmacologic Class
Usage Information
Busulfan is used to treat chronic myelogenous leukemia (CML). It does not cure the disease but helps to control it so that your quality of life is improved.

Regulatory & Marketing

Labeler Name
Waylis Therapeutics Llc
Product Type
Human Prescription Drug
FDA Application #
NDA009386
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-15-2023
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.

None
Source: PDAC
BUSULFAN, 2 MG, ORAL
HCPCS Dosage 2 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 80725-620-25 identifies a specific commercial package of 25 tablet, film coated in 1 bottle of Myleran, a human prescription drug labeled by Waylis Therapeutics Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 25 billable units per package. This tablet, film coated is formulated for oral 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 Waylis Therapeutics Llc on May 15, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Busulfan is used to treat chronic myelogenous leukemia (CML). It does not cure the disease but helps to control it so that your quality of life is improved.

How is this Waylis Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80725062025. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 25 total billable units per package. 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)
80725-620-25
11-Digit CMS (5-4-2)
80725-0620-25

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