FDA.reportPublic FDA data

afatinib 20 MG Oral Tablet

RxCUI
1430446
RxNorm name
afatinib 20 MG Oral Tablet
Display name
afatinib 20 MG Oral Tablet
Full name
afatinib 20 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AfatinibAFATINIBCamber Pharmaceuticals, Inc.ec5b9e00-3eab-4dbd-9bb3-75865b1af4852026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 1430446
GilotrifAFATINIBBoehringer Ingelheim Pharmaceuticals, Inc.fd638e5e-8032-e7ca-0179-95e96ab5d3872025-11-13Warnings, Adverse reactionsExact identifier
rxcui: 1430446

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
fd638e5e-8032-e7ca-0179-95e96ab5d387afatinib 20 MG Oral Tablet [PSN] · afatinib 20 MG Oral Tablet [SCD] · afatinib 20 MG (as afatinib dimaleate 29.56 MG) Oral Tablet [SY]320These highlights do not include all the information needed to use GILOTRIF safely and effectively. See full prescribing information for GILOTRIF. GILOTRIF ® (afatinib tablets), for oral use Initial U.S. Approval: 201320251113