FDA.reportPublic FDA data

Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG

RxCUI
2630160
RxNorm name
Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG
Display name
Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG
Full name
Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG
Term type
SY
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#

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
AustedoDEUTETRABENAZINETeva Neuroscience, Inc.7ea3c60a-45c7-44cc-afc2-d87fa53993c02025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2630160

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-d87fa53993c0{14 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo]) / 14 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo]) / 14 (24 HR deutetrabenazine 6 MG Extended Release Oral Tablet [Austedo]) } Pack [Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG] [BPCK] · Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG [PSN] · Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG [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