FDA.reportPublic FDA data

{14 (deutetrabenazine 12 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose, 4 Week Titration Pack]

RxCUI
2541519
RxNorm name
{14 (deutetrabenazine 12 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose, 4 Week Titration Pack]
Display name
{14 (deutetrabenazine 12 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose, 4 Week Titration Pack]
Full name
{14 (deutetrabenazine 12 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose, 4 Week Titration Pack]
Term type
BPCK
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: 2541519

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
7ea3c60a-45c7-44cc-afc2-d87fa53993c0{14 (deutetrabenazine 12 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose, 4 Week Titration Pack]BPCK35These 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
7ea3c60a-45c7-44cc-afc2-d87fa53993c0Austedo 12 MG Starting Dose, 4 Week Titration PackPSN35These 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
7ea3c60a-45c7-44cc-afc2-d87fa53993c0Austedo 12 MG Starting Dose, 4 Week Titration PackSY35These 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