FDA.reportPublic FDA data

baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Injection

RxCUI
1300890
RxNorm name
baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Injection
Display name
baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Injection
Full name
baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Injection
Term type
PSN
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 · 4 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: 1300890
BACLOFENBACLOFENAdvagen Pharma Limitedd63af5f0-c275-480b-89b5-6cf1ad55ab632025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1300890
BaclofenBACLOFENSagent Pharmaceuticalsd4bfba33-9f4d-4c43-ae6c-bcf67ef8fe512025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1300890
BaclofenBACLOFENMAlA Pharmaceuticals, Inc.dfa6148c-693c-45f1-89be-0e77d39f313e2023-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1300890

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 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) Injection [PSN] · 20 ML baclofen 1 MG/ML Injection [SCD] · baclofen 20,000 MCG per 20 ML Injection [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
d63af5f0-c275-480b-89b5-6cf1ad55ab63baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Injection [PSN] · 20 ML baclofen 1 MG/ML Injection [SCD] · baclofen 20,000 MCG per 20 ML Injection [SY]36These highlights do not include all the information needed to use BACLOFEN INJECTION safely and effectively. See full prescribing information for BACLOFEN INJECTION BACLOFEN injection, for intrathecal use Initial U.S. Approval: 199220251209
dfa6148c-693c-45f1-89be-0e77d39f313ebaclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Injection [PSN] · 20 ML baclofen 1 MG/ML Injection [SCD] · baclofen 20,000 MCG per 20 ML Injection [SY]34These highlights do not include all the information needed to use BACLOFEN INJECTION safely and effectively. See full prescribing information for BACLOFEN INJECTION.Initial U.S. Approval: 199220230115
d4bfba33-9f4d-4c43-ae6c-bcf67ef8fe51baclofen 20,000 MCG in 20 ML (1,000 MCG/ML) Injection [PSN] · 20 ML baclofen 1 MG/ML Injection [SCD] · baclofen 20,000 MCG per 20 ML Injection [SY]32These highlights do not include all the information needed to use BACLOFEN INJECTION safely and effectively. See full prescribing information for BACLOFEN INJECTION. BACLOFEN injection, for intrathecal use Initial U.S. Approval: 199220250505