FDA.reportPublic FDA data

Otrexup 15 MG per 0.4 ML Auto-Injector

RxCUI
1441413
RxNorm name
Otrexup 15 MG per 0.4 ML Auto-Injector
Display name
Otrexup 15 MG per 0.4 ML Auto-Injector
Full name
Otrexup 15 MG per 0.4 ML Auto-Injector
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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: 1441413

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 15 MG in 0.4 ML Auto-Injector [PSN] · 0.4 ML methotrexate 37.5 MG/ML Auto-Injector [Otrexup] [SBD] · 0.4 ML Otrexup 37.5 MG/ML Auto-Injector [SY] · Otrexup 15 MG per 0.4 ML Auto-Injector [SY] · Otrexup 37.5 MG/ML in 0.4 ML Auto-Injector [SY]515These 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