FDA.reportPublic FDA data

Horizant (as gabapentin enacarbil) 300 MG Extended Release Oral Tablet

RxCUI
1482821
RxNorm name
Horizant (as gabapentin enacarbil) 300 MG Extended Release Oral Tablet
Display name
Horizant (as gabapentin enacarbil) 300 MG Extended Release Oral Tablet
Full name
Horizant (as gabapentin enacarbil) 300 MG Extended Release Oral Tablet
Term type
SY
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: 1482821

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
4c486fc7-c8c4-4c6c-b30c-366dabaeaaddHorizant 300 MG Extended Release Oral Tablet [PSN] · gabapentin enacarbil 300 MG Extended Release Oral Tablet [Horizant] [SBD] · Horizant (as gabapentin enacarbil) 300 MG Extended Release Oral Tablet [SY]316These 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