What is NDC 80725-620?

80725-620 is the product NDC for Myleran (busulfan), Busulfan 2 mg/1 tablet, film coated, listed with the FDA by Waylis Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Waylis Therapeutics LLC, NDC labeler code 80725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Myleran?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Myleran NDC 80725-620 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80725-620Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80725-0620Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
80725-620-25	8072506202580725062025	25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25)Marketed from May 15, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Myleran
Generic name (nonproprietary): busulfan
Active ingredients: Busulfan — 2 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Waylis Therapeutics LLCNDC labeler code 80725
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 009386
Marketing start: May 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 80725-620_da6a0ae8-6165-4e4f-b759-600cd940d252SPL ID da6a0ae8-6165-4e4f-b759-600cd940d252SPL set ID 2da33e5b-dcfb-4cdf-b163-50398e42f41cRxCUI 105551, 197422UNII G1LN9045DK
Pharmacologic class: Alkylating Drug

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480725062025 followed by a unit qualifier and the quantity

Package 80725-0620-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 8, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80725-620

What is NDC 80725-620?: 80725-620 is the product NDC for Myleran (busulfan), Busulfan 2 mg/1 tablet, film coated, listed with the FDA by Waylis Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Myleran (Busulfan).
What is the active ingredient?: Busulfan.
Who is the labeler?: Waylis Therapeutics LLC, NDC labeler code 80725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Myleran?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Myleran (Busulfan) NDC 80725-620