FDA.reportPublic FDA data

20 ML baclofen 1 MG/ML Prefilled Syringe

RxCUI
1369787
RxNorm name
20 ML baclofen 1 MG/ML Prefilled Syringe
Display name
20 ML baclofen 1 MG/ML Prefilled Syringe
Full name
20 ML baclofen 1 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

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
GablofenBACLOFEN INJECTIONPiramal Critical Care Inc00d3e846-dd92-448d-9ab8-6a07be823cc12026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1369787

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-9ab8-6a07be823cc1baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Prefilled Syringe [PSN] · 20 ML baclofen 1 MG/ML Prefilled Syringe [SCD] · baclofen 20,000 MCG per 20 ML Prefilled Syringe [SY]343These 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