FDA.reportPublic FDA data

0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]

RxCUI
2703026
RxNorm name
0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]
Display name
0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]
Full name
0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo]
Term type
SBD
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)Disc2026-09-01

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
bb6dba23-e7a6-4765-a1e6-b9e277ce0381Niktimvo 9 MG in 0.18 ML Injection [PSN] · 0.18 ML axatilimab-csfr 50 MG/ML Injection [Niktimvo] [SBD] · 0.18 ML Niktimvo 50 MG/ML Injection [SY] · Niktimvo 9 MG per 0.18 ML Injection [SY]45These 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