FDA.reportPublic FDA data

deutetrabenazine 12 MG 24HR Extended Release Oral Tablet

RxCUI
2630144
RxNorm name
deutetrabenazine 12 MG 24HR Extended Release Oral Tablet
Display name
deutetrabenazine 12 MG 24HR Extended Release Oral Tablet
Full name
deutetrabenazine 12 MG 24HR Extended Release Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

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
AustedoDEUTETRABENAZINETeva Neuroscience, Inc.7ea3c60a-45c7-44cc-afc2-d87fa53993c02025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2630144

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
7ea3c60a-45c7-44cc-afc2-d87fa53993c0deutetrabenazine 12 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [SCD] · deutetrabenazine 12 MG 24 HR Extended Release Oral Tablet [SY]335These highlights do not include all the information needed to use AUSTEDO XR or AUSTEDO safely and effectively. See full prescribing information for AUSTEDO XR and AUSTEDO . AUSTEDO XR ® (deutetrabenazine) extended-release tablets, for oral use AUSTEDO ® (deutetrabenazine) tablets, for oral use Initial U.S. Approval: 201720250228