FDA.reportPublic FDA data

gabapentin enacarbil 300 MG Extended Release Oral Tablet

RxCUI
1482820
RxNorm name
gabapentin enacarbil 300 MG Extended Release Oral Tablet
Display name
gabapentin enacarbil 300 MG Extended Release Oral Tablet
Full name
gabapentin enacarbil 300 MG Extended Release Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:57

RxNav Current And Historical NDCs#

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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
HorizantGABAPENTIN ENACARBILAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)4c486fc7-c8c4-4c6c-b30c-366dabaeaadd2025-04-28Warnings, Adverse reactionsExact identifier
rxcui: 1482820

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
4c486fc7-c8c4-4c6c-b30c-366dabaeaaddgabapentin enacarbil 300 MG Extended Release Oral TabletSCD16These highlights do not include all the information needed to use HORIZANT safely and effectively. See full prescribing information for HORIZANT. HORIZANT ® (gabapentin enacarbil) extended-release tablets, for oral use Initial U.S. Approval: 201120250428
4c486fc7-c8c4-4c6c-b30c-366dabaeaaddgabapentin enacarbil 300 MG Extended Release Oral TabletPSN16These highlights do not include all the information needed to use HORIZANT safely and effectively. See full prescribing information for HORIZANT. HORIZANT ® (gabapentin enacarbil) extended-release tablets, for oral use Initial U.S. Approval: 201120250428