Prescription drug · BLA
Niktimvo (Axatilimab-csfr) NDC 50881-036
Axatilimab 9 mg/.9mL · Injection · Intravenous · Incyte Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50881-036-17 | 50881003617 | 1 VIAL, SINGLE-USE in 1 CARTON (50881-036-17) / .9 mL in 1 VIAL, SINGLE-USEMarketed from Jun 24, 2026 |
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)
- Niktimvo
- Generic name (nonproprietary)
- axatilimab-csfr
- Active ingredients
- Axatilimab — 9 mg/.9mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Incyte CorporationNDC labeler code 50881
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761411
- Marketing start
- Listing expires
- Other FDA classes
- Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors (Mechanism)
- Identifiers
- Product ID 50881-036_957af5d1-7d9d-459e-a551-2301e3ca6a22SPL ID 957af5d1-7d9d-459e-a551-2301e3ca6a22
- Pharmacologic class
- Colony Stimulating Factor-1 Receptor Blocker
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
N450881003617followed by a unit qualifier and the quantityPackage 50881-0036-17. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 50881-036
- What is NDC 50881-036?
- 50881-036 is the product NDC for Niktimvo (axatilimab-csfr), Axatilimab 9 mg/.9mL injection, listed with the FDA by Incyte Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Niktimvo (Axatilimab-csfr).
- What is the active ingredient?
- Axatilimab.
- Who is the labeler?
- Incyte Corporation, NDC labeler code 50881. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Niktimvo?
- 3 other product NDCs are listed under this name. See all Niktimvo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Niktimvo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Niktimvoaxatilimab-csfr | Axatilimab 22 mg/2.2mL | InjectionIntravenous | Incyte Corporation | 50881-047 | 50881-0047-18 |
| Niktimvoaxatilimab-csfr | Axatilimab 22 mg/.44mL | InjectionIntravenous | Incyte Corporation | 50881-023 | 50881-0023-11 |
| Niktimvoaxatilimab-csfr | Axatilimab 9 mg/.18mL | InjectionIntravenous | Incyte Corporation | 50881-034 | 50881-0034-12 |
Other NDCs under BLA 761411
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 |
|---|---|---|---|---|
| Niktimvoaxatilimab-csfr | Axatilimab 22 mg/.44mL | InjectionIntravenous | Incyte Corporation | 50881-023 |
| Niktimvoaxatilimab-csfr | Axatilimab 9 mg/.18mL | InjectionIntravenous | Incyte Corporation | 50881-034 |
| Niktimvoaxatilimab-csfr | Axatilimab 22 mg/2.2mL | InjectionIntravenous | Incyte Corporation | 50881-047 |