FDA.reportPublic FDA data

Gablofen 10,000 MCG per 20 ML Injection

RxCUI
1047444
RxNorm name
Gablofen 10,000 MCG per 20 ML Injection
Display name
Gablofen 10,000 MCG per 20 ML Injection
Full name
Gablofen 10,000 MCG per 20 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

RxNav Current And Historical NDCs#

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UNII Substances#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GablofenBACLOFEN INJECTIONPiramal Critical Care Inc00d3e846-dd92-448d-9ab8-6a07be823cc12026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1047444

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
00d3e846-dd92-448d-9ab8-6a07be823cc1Gablofen 10,000 MCG in 20 ML (500 MCG/ML) Injection [PSN] · 20 ML baclofen 0.5 MG/ML Injection [Gablofen] [SBD] · 20 ML Gablofen 0.5 MG/ML Injection [SY] · Gablofen 10,000 MCG per 20 ML Injection [SY] · Gablofen 500 MCG per 1 ML Injection [SY]543These highlights do not include all the information needed to use GABLOFEN ® safely and effectively. See full prescribing information for GABLOFEN. GABLOFEN (baclofen injection), for intrathecal use Initial U.S. Approval: 199220260507