FDA.reportPublic FDA data

NIKTIMVO

Product NDC
50881-034
11-digit product format
508810034
Labeler code
50881
Product ID
50881-034_fa4bffb4-d6af-4a71-9e0f-686dcca75a24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
axatilimab-csfr
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Incyte Corporation
Application
BLA761411
Marketing category
BLA
Marketing start
2025-01-15
Substance
AXATILIMAB
Active strength
9 mg/.18mL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NIKTIMVO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AXATILIMAB9 mg/.18mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR96Z451BMC
Rxcui2691534, 2691541, 2703023, 2703024, 2703025, 2703026

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50881-034-12NIKTIMVO1 in 1 CARTONINJECTION15
50881-034-12NIKTIMVO0.18 mL in 1 VIAL, SINGLE-USEINJECTION0.185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50881-034-12ML - Milliliter50881-034525696b8-f401-4af4-a6c7-7bc581389caa12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50881-034NIKTIMVO (AXATILIMAB-CSFR) INJECTION [INCYTE CORPORATION]3Current NDC, 2 package rows20250130_bb6dba23-e7a6-4765-a1e6-b9e277ce0381.zip

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 startSampleExclude flagStatus
50881-034-12508810034121 VIAL, SINGLE-USE in 1 CARTON (50881-034-12) / .18 mL in 1 VIAL, SINGLE-USE2025-01-15NoNoCurrent