Home NDC 50881-012 NIKTIMVO
Product NDC 50881-012
11-digit product format 508810012
Labeler code 50881
Product ID 50881-012_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 2024-08-14
Substance AXATILIMAB
Active strength 50 mg/mL
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AXATILIMAB 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R96Z451BMC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2691534 Internal RxNorm lookup 2691541 Internal RxNorm lookup 2703023 Internal RxNorm lookup 2703024 Internal RxNorm lookup 2703025 Internal RxNorm lookup 2703026 Internal RxNorm lookup 2746546 Internal RxNorm lookup 2746549 Internal RxNorm lookup 2746551 Internal RxNorm lookup 2746552 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50881-012-10 NIKTIMVO 1 in 1 CARTON INJECTION 1 5 50881-012-10 NIKTIMVO 1 mL in 1 VIAL, SINGLE-USE INJECTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50881-012 NIKTIMVO (AXATILIMAB-CSFR) INJECTION [INCYTE CORPORATION] 3 Current NDC, 2 package rows 20250130_bb6dba23-e7a6-4765-a1e6-b9e277ce0381.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761411 Niktimvo axatilimab-csfr 351(a) Disc 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50881-012-10 50881001210 1 VIAL, SINGLE-USE in 1 CARTON (50881-012-10) / 1 mL in 1 VIAL, SINGLE-USE 2024-08-14 No No Current