Grafapex (treosulfan) NDC 59137-365

NDC codes

FDA NDC Directory

Product NDC (as listed)59137-365Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59137-0365Add 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
59137-365-01	59137036501	1 VIAL in 1 CARTON (59137-365-01) / 5 g in 1 VIALMarketed from Jan 28, 2025

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): Grafapex
Generic name (nonproprietary): treosulfan
Active ingredients: Treosulfan — 5000 mg/5g
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Medexus Pharma, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 214759
Marketing start: Jan 28, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 59137-365_2d06b03c-17aa-0492-e063-6294a90abd8fSPL ID 2d06b03c-17aa-0492-e063-6294a90abd8fSPL set ID 2d06b03c-17aa-0492-e063-6294a90abd8fRxCUI 2703570, 2703575, 2703577, 2703579UNII CO61ER3EPI

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N459137036501 followed by a unit qualifier and the quantity

Package 59137-0365-01. 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 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). ( 1.1 ). Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). ( 1.2 ). 1.1 Acute Myeloid Leukemia GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age an…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 214759

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 214759
Product	Strength	Form · route	Labeler	Product NDC
Grafapextreosulfan	Treosulfan 1000 mg/g	Injection, Powder, Lyophilized, For solutionIntravenous	Medexus Pharma, Inc.	59137-335