FDA.reportPublic FDA data

2.4 ML aripiprazole lauroxil 281.3 MG/ML Prefilled Syringe [Aristada]

RxCUI
2049343
RxNorm name
2.4 ML aripiprazole lauroxil 281.3 MG/ML Prefilled Syringe [Aristada]
Display name
2.4 ML aripiprazole lauroxil 281.3 MG/ML Prefilled Syringe [Aristada]
Full name
2.4 ML aripiprazole lauroxil 281.3 MG/ML Prefilled Syringe [Aristada]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:16

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
ARISTADA INITIOARIPIPRAZOLE LAUROXILAlkermes, Inc.b18fdfd9-31cd-4a2f-9f1c-ebc70d7a94032025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2049343

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
b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403Aristada Initio Starter Dose 675 MG in 2.4 ML Prefilled Syringe [PSN] · 2.4 ML aripiprazole lauroxil 281.3 MG/ML Prefilled Syringe [Aristada] [SBD] · 2.4 ML Aristada 281.25 MG/ML Extended Release Suspension Prefilled Syringe [SY] · Aristada 675 MG per 2.4 ML Prefilled Syringe [SY] · Aristada Initio Starter Dose 281.3 MG/ML per 2.4 ML Prefilled Syringe [SY]516These highlights do not include all the information needed to use ARISTADA INITIO ® safely and effectively. See full prescribing information for ARISTADA INITIO ® . ARISTADA INITIO ® (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use Initial U.S. Approval: 201520250128