FDA.reportPublic FDA data

0.4 ML Otrexup 18.8 MG/ML Auto-Injector

RxCUI
1594759
RxNorm name
0.4 ML Otrexup 18.8 MG/ML Auto-Injector
Display name
0.4 ML Otrexup 18.8 MG/ML Auto-Injector
Full name
0.4 ML Otrexup 18.8 MG/ML Auto-Injector
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

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
OtrexupMETHOTREXATEAntares Pharma, Inc.9ab8ce16-f7de-41d4-a4c8-1c742621b6d52025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1594759

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
9ab8ce16-f7de-41d4-a4c8-1c742621b6d5Otrexup 7.5 MG in 0.4 ML Auto-Injector [PSN] · 0.4 ML methotrexate 18.8 MG/ML Auto-Injector [Otrexup] [SBD] · 0.4 ML Otrexup 18.8 MG/ML Auto-Injector [SY] · Otrexup 7.5 MG per 0.4 ML Auto-Injector [SY]415These highlights do not include all the information needed to use OTREXUP™ safely and effectively. See full prescribing information for OTREXUP . OTREXUP (methotrexate) injection, for subcutaneous use Initial U.S. Approval: 195320250131