FDA.reportPublic FDA data

NIKTIMVO

Product NDC
50881-036
11-digit product format
508810036
Labeler code
50881
Product ID
50881-036_b6b9ef2d-53cd-47c7-9ee5-c0610635d35b
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]
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIKTIMVOAXATILIMAB-CSFRIncyte Corporationbb6dba23-e7a6-4765-a1e6-b9e277ce03812026-06-24Warnings, Adverse reactionsExact identifier
application number: BLA761411
ndc (product): 50881-036

Additional Listing Data#

Finished product
Yes
Brand name base
NIKTIMVO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AXATILIMAB9 mg/.9mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R96Z451BMCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2691534Internal RxNorm lookup
2691541Internal RxNorm lookup
2703023Internal RxNorm lookup
2703024Internal RxNorm lookup
2703025Internal RxNorm lookup
2703026Internal RxNorm lookup
2746546Internal RxNorm lookup
2746549Internal RxNorm lookup
2746551Internal RxNorm lookup
2746552Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb6dba23-e7a6-4765-a1e6-b9e277ce0381Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
87027077-8707-4994-8e5f-8e2b71e484e3Product name120250317
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761411Niktimvoaxatilimab-csfr351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2703023axatilimab-csfr 22 MG in 0.44 ML InjectionPSNbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2691534axatilimab-csfr 50 MG in 1 ML InjectionPSNbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2703025axatilimab-csfr 9 MG in 0.18 ML InjectionPSNbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2703024Niktimvo 22 MG in 0.44 ML InjectionPSNbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2691541Niktimvo 50 MG in 1 ML InjectionPSNbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2703026Niktimvo 9 MG in 0.18 ML InjectionPSNbb6dba23-e7a6-4765-a1e6-b9e277ce03815
27030260.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]SBDbb6dba23-e7a6-4765-a1e6-b9e277ce03815
27030240.44 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]SBDbb6dba23-e7a6-4765-a1e6-b9e277ce03815
26915411 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]SBDbb6dba23-e7a6-4765-a1e6-b9e277ce03815
27030250.18 ML axatilimab-csfr 50 MG/ML InjectionSCDbb6dba23-e7a6-4765-a1e6-b9e277ce03815
27030230.44 ML axatilimab-csfr 50 MG/ML InjectionSCDbb6dba23-e7a6-4765-a1e6-b9e277ce03815
26915341 ML axatilimab-csfr 50 MG/ML InjectionSCDbb6dba23-e7a6-4765-a1e6-b9e277ce03815
27030260.18 ML Niktimvo 50 MG/ML InjectionSYbb6dba23-e7a6-4765-a1e6-b9e277ce03815
27030240.44 ML Niktimvo 50 MG/ML InjectionSYbb6dba23-e7a6-4765-a1e6-b9e277ce03815
26915411 ML Niktimvo 50 MG/ML InjectionSYbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2703023axatilimab-csfr 22 MG per 0.44 ML InjectionSYbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2691534axatilimab-csfr 50 MG per 1 ML InjectionSYbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2703025axatilimab-csfr 9 MG per 0.18 ML InjectionSYbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2703024Niktimvo 22 MG per 0.44 ML InjectionSYbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2691541Niktimvo 50 MG per 1 ML InjectionSYbb6dba23-e7a6-4765-a1e6-b9e277ce03815
2703026Niktimvo 9 MG per 0.18 ML InjectionSYbb6dba23-e7a6-4765-a1e6-b9e277ce03815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
50881-036-17508810036171 VIAL, SINGLE-USE in 1 CARTON (50881-036-17) / .9 mL in 1 VIAL, SINGLE-USE2026-06-240Current