What is NDC 80725-610?

80725-610 is the product NDC for Leukeran (chlorambucil), Chlorambucil 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 Leukeran?

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.

Leukeran NDC 80725-610 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80725-610Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80725-0610Add 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
80725-610-25	80725061025	25 TABLET, FILM COATED in 1 BOTTLE (80725-610-25)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): Leukeran
Generic name (nonproprietary): chlorambucil
Active ingredients: Chlorambucil — 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 010669
Marketing start: May 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 80725-610_5a3f7aed-1747-4c52-9e10-5aa090dd088eSPL ID 5a3f7aed-1747-4c52-9e10-5aa090dd088eSPL set ID 58a3c995-5ad6-465d-8437-5970c9088213RxCUI 105553, 197462UNII 18D0SL7309
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

N480725061025 followed by a unit qualifier and the quantity

Package 80725-0610-25. 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 LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is not curative in any of these disorders but may produce clinically useful palliation.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80725-610

What is NDC 80725-610?: 80725-610 is the product NDC for Leukeran (chlorambucil), Chlorambucil 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?: Leukeran (Chlorambucil).
What is the active ingredient?: Chlorambucil.
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 Leukeran?: 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.

Leukeran (Chlorambucil) NDC 80725-610