FDA.reportPublic FDA data

{14 (deutetrabenazine 12 MG Oral Tablet) / 21 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } Pack

RxCUI
2541520
RxNorm name
{14 (deutetrabenazine 12 MG Oral Tablet) / 21 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } Pack
Display name
{14 (deutetrabenazine 12 MG Oral Tablet) / 21 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } Pack
Full name
{14 (deutetrabenazine 12 MG Oral Tablet) / 21 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } Pack
Term type
GPCK
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: 2541520

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 (deutetrabenazine 12 MG Oral Tablet) / 21 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } Pack [GPCK] · deutetrabenazine starter pack 6 MG (21), 9 MG (14), 12 MG (14) Oral Tablet 4 Week Pack [PSN] · deutetrabenazine starter pack 6 MG (21), 9 MG (14), 12 MG (14) Oral Tablet 4 Week Pack [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