FDA.reportPublic FDA data

1 ML Niktimvo 50 MG/ML Injection

RxCUI
2691541
RxNorm name
1 ML Niktimvo 50 MG/ML Injection
Display name
1 ML Niktimvo 50 MG/ML Injection
Full name
1 ML Niktimvo 50 MG/ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:18

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761411Niktimvoaxatilimab-csfr351(a)Disc2026-07-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIKTIMVOAXATILIMAB-CSFRIncyte Corporationbb6dba23-e7a6-4765-a1e6-b9e277ce03812026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 2691541

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
bb6dba23-e7a6-4765-a1e6-b9e277ce03811 ML Niktimvo 50 MG/ML InjectionSY5These highlights do not include all the information needed to use NIKTIMVO safely and effectively. See full prescribing information for NIKTIMVO. NIKTIMVO™ (axatilimab-csfr) injection, for intravenous use Initial U.S. Approval: 202420250116
bb6dba23-e7a6-4765-a1e6-b9e277ce0381Niktimvo 50 MG in 1 ML InjectionPSN5These highlights do not include all the information needed to use NIKTIMVO safely and effectively. See full prescribing information for NIKTIMVO. NIKTIMVO™ (axatilimab-csfr) injection, for intravenous use Initial U.S. Approval: 202420250116
bb6dba23-e7a6-4765-a1e6-b9e277ce0381Niktimvo 50 MG per 1 ML InjectionSY5These highlights do not include all the information needed to use NIKTIMVO safely and effectively. See full prescribing information for NIKTIMVO. NIKTIMVO™ (axatilimab-csfr) injection, for intravenous use Initial U.S. Approval: 202420250116
bb6dba23-e7a6-4765-a1e6-b9e277ce03811 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]SBD5These highlights do not include all the information needed to use NIKTIMVO safely and effectively. See full prescribing information for NIKTIMVO. NIKTIMVO™ (axatilimab-csfr) injection, for intravenous use Initial U.S. Approval: 202420250116