Prescription drug · NDA
Grafapex (Treosulfan) NDC 59137-335
Treosulfan 1000 mg/g · Injection, Powder, Lyophilized, For solution · Intravenous · Medexus Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59137-335-01 | 5913703350159137033501 | 1 VIAL in 1 CARTON (59137-335-01) / 1 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 — 1000 mg/g
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Medexus Pharma, Inc.NDC labeler code 59137
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214759
- Marketing start
- Listing expires
- Identifiers
- Product ID 59137-335_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.
- NDC on a medical claim
N459137033501followed by a unit qualifier and the quantityPackage 59137-0335-01. 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 . 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.
About NDC 59137-335
- What is NDC 59137-335?
- 59137-335 is the product NDC for Grafapex (treosulfan), Treosulfan 1000 mg/g injection, powder, lyophilized, for solution, listed with the FDA by Medexus Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Grafapex (Treosulfan).
- What is the active ingredient?
- Treosulfan.
- Who is the labeler?
- Medexus Pharma, Inc., NDC labeler code 59137. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Grafapex?
- 1 other product NDC are listed under this name. See all Grafapex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Grafapex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Grafapextreosulfan | Treosulfan 5000 mg/5g | Injection, Powder, Lyophilized, For solutionIntravenous | Medexus Pharma, Inc. | 59137-365 | 59137-0365-01 |
Other NDCs under NDA 214759
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Grafapextreosulfan | Treosulfan 5000 mg/5g | Injection, Powder, Lyophilized, For solutionIntravenous | Medexus Pharma, Inc. | 59137-365 |