FDA.reportPublic FDA data

naltrexone 380 MG Injection [Vivitrol]

RxCUI
637216
RxNorm name
naltrexone 380 MG Injection [Vivitrol]
Display name
naltrexone 380 MG Injection [Vivitrol]
Full name
naltrexone 380 MG Injection [Vivitrol]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:21

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

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
VIVITROLNALTREXONEAlkermes, Inc.cd11c435-b0f0-4bb9-ae78-60f101f3703f2026-05-31Warnings, Adverse reactionsExact identifier
rxcui: 637216

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
cd11c435-b0f0-4bb9-ae78-60f101f3703fVivitrol 380 MG Injection [PSN] · naltrexone 380 MG Injection [Vivitrol] [SBD] · Vivitrol 380 MG Injection [SY]338These highlights do not include all the information needed to use VIVITROL ® safely and effectively. See full prescribing information for VIVITROL. VIVITROL (naltrexone for extended-release injectable suspension), for intramuscular use Initial U.S. Approval: 198420251223