FDA.reportPublic FDA data

NERLYNX 40 MG Oral Tablet

RxCUI
1940654
RxNorm name
NERLYNX 40 MG Oral Tablet
Display name
NERLYNX 40 MG Oral Tablet
Full name
NERLYNX 40 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

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
NerlynxNERATINIBPuma Biotechnology, Inc.d1e41dcf-e82a-47c2-a0ad-6c6eef6218342026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 1940654

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
d1e41dcf-e82a-47c2-a0ad-6c6eef621834NERLYNX 40 MG Oral Tablet [PSN] · neratinib 40 MG Oral Tablet [Nerlynx] [SBD] · Nerlynx 40 MG (as neratinib maleate 48.31 MG) Oral Tablet [SY]318These highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 201720251201