FDA.reportPublic FDA data

1 ML baclofen 0.05 MG/ML Prefilled Syringe

RxCUI
1047437
RxNorm name
1 ML baclofen 0.05 MG/ML Prefilled Syringe
Display name
1 ML baclofen 0.05 MG/ML Prefilled Syringe
Full name
1 ML baclofen 0.05 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 · 3 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: 1047437
BaclofenBACLOFENMAlA Pharmaceuticals, Inc.e05080ef-53d9-4060-aaa4-86a6935467de2023-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1047437
BaclofenBACLOFENSagent Pharmaceuticalsea32c39c-0ee3-4b5e-8da7-4c31db334bd82021-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1047437

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
00d3e846-dd92-448d-9ab8-6a07be823cc11 ML baclofen 0.05 MG/ML Prefilled SyringeSCD43These 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
00d3e846-dd92-448d-9ab8-6a07be823cc1baclofen 50 MCG per 1 ML Prefilled SyringeSY43These 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
00d3e846-dd92-448d-9ab8-6a07be823cc1baclofen 50 MCG in 1 ML Prefilled SyringePSN43These 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
e05080ef-53d9-4060-aaa4-86a6935467debaclofen 50 MCG per 1 ML Prefilled SyringeSY320230314
e05080ef-53d9-4060-aaa4-86a6935467de1 ML baclofen 0.05 MG/ML Prefilled SyringeSCD320230314
e05080ef-53d9-4060-aaa4-86a6935467debaclofen 50 MCG in 1 ML Prefilled SyringePSN320230314
ea32c39c-0ee3-4b5e-8da7-4c31db334bd8baclofen 50 MCG in 1 ML Prefilled SyringePSN1Baclofen Injection, USP*20210624
ea32c39c-0ee3-4b5e-8da7-4c31db334bd8baclofen 50 MCG per 1 ML Prefilled SyringeSY1Baclofen Injection, USP*20210624
ea32c39c-0ee3-4b5e-8da7-4c31db334bd81 ML baclofen 0.05 MG/ML Prefilled SyringeSCD1Baclofen Injection, USP*20210624