NIKTIMVO
- Product NDC
- 50881-036
- 11-digit product format
- 508810036
- Labeler code
- 50881
- Product ID
- 50881-036_957af5d1-7d9d-459e-a551-2301e3ca6a22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- axatilimab-csfr
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Incyte Corporation
- Application
- BLA761411
- Marketing category
- BLA
- Marketing start
- 2026-06-24
- Substance
- AXATILIMAB
- Active strength
- 9 mg/.9mL
- Pharmacologic classes
- Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Colony Stimulating Factor-1 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NIKTIMVO
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AXATILIMAB | 9 mg/.9mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 87027077-8707-4994-8e5f-8e2b71e484e3 | Product name | 1 | 20250317 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761411 | Niktimvo | axatilimab-csfr | 351(a) | Disc | 2026-09-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2703023 | axatilimab-csfr 22 MG in 0.44 ML Injection | PSN | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2691534 | axatilimab-csfr 50 MG in 1 ML Injection | PSN | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703025 | axatilimab-csfr 9 MG in 0.18 ML Injection | PSN | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703024 | Niktimvo 22 MG in 0.44 ML Injection | PSN | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2691541 | Niktimvo 50 MG in 1 ML Injection | PSN | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703026 | Niktimvo 9 MG in 0.18 ML Injection | PSN | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703026 | 0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo] | SBD | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703024 | 0.44 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo] | SBD | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2691541 | 1 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo] | SBD | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703025 | 0.18 ML axatilimab-csfr 50 MG/ML Injection | SCD | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703023 | 0.44 ML axatilimab-csfr 50 MG/ML Injection | SCD | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2691534 | 1 ML axatilimab-csfr 50 MG/ML Injection | SCD | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703026 | 0.18 ML Niktimvo 50 MG/ML Injection | SY | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703024 | 0.44 ML Niktimvo 50 MG/ML Injection | SY | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2691541 | 1 ML Niktimvo 50 MG/ML Injection | SY | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703023 | axatilimab-csfr 22 MG per 0.44 ML Injection | SY | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2691534 | axatilimab-csfr 50 MG per 1 ML Injection | SY | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703025 | axatilimab-csfr 9 MG per 0.18 ML Injection | SY | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703024 | Niktimvo 22 MG per 0.44 ML Injection | SY | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2691541 | Niktimvo 50 MG per 1 ML Injection | SY | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
| 2703026 | Niktimvo 9 MG per 0.18 ML Injection | SY | bb6dba23-e7a6-4765-a1e6-b9e277ce0381 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 50881-036-17 | 50881003617 | 1 VIAL, SINGLE-USE in 1 CARTON (50881-036-17) / .9 mL in 1 VIAL, SINGLE-USE | 2026-06-24 | No | No | Current |