FDA.reportPublic FDA data

carglumic acid 200 MG Dispersible Tablet for Oral Suspension

RxCUI
905390
RxNorm name
carglumic acid 200 MG Dispersible Tablet for Oral Suspension
Display name
carglumic acid 200 MG Dispersible Tablet for Oral Suspension
Full name
carglumic acid 200 MG Dispersible Tablet for Oral Suspension
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

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
Carglumic AcidCARGLUMIC ACIDEton Pharmaceuticals, Inc.591f95ca-3d99-4fb6-a402-e5a383a746d02026-03-03Adverse reactionsExact identifier
rxcui: 905390
Carglumic acidCARGLUMIC ACIDNavinta LLC59e73eb8-edf8-4fad-93c2-deb6b23497f82024-03-23Adverse reactionsExact identifier
rxcui: 905390
Carglumic acidCARGLUMIC ACIDBurel Pharmaceuticals, LLC2aee4281-402b-4cd6-9e6a-08945262e1a12024-03-19Adverse reactionsExact identifier
rxcui: 905390
CarbagluCARGLUMIC ACIDRecordati Rare Diseases10175e73-5172-4dde-a508-8a88b7afc0a12024-01-25Adverse reactionsExact identifier
rxcui: 905390

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
10175e73-5172-4dde-a508-8a88b7afc0a1carglumic acid 200 MG Tablet for Oral Suspension [PSN] · carglumic acid 200 MG Tablet for Oral Suspension [SCD] · carglumic acid 200 MG Dispersible Tablet for Oral Suspension [SY]336These highlights do not include all the information needed to use CARBAGLU safely and effectively. See full prescribing information for CARBAGLU. Carbaglu ® (carglumic acid) tablets for oral suspension Initial U.S. Approval: 201020240125
591f95ca-3d99-4fb6-a402-e5a383a746d0carglumic acid 200 MG Tablet for Oral Suspension [PSN] · carglumic acid 200 MG Tablet for Oral Suspension [SCD] · carglumic acid 200 MG Dispersible Tablet for Oral Suspension [SY]34These highlights do not include all the information needed to use CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION. CARGLUMIC ACID tablets for oral suspension Initial U.S. Approval: 201020260303
59e73eb8-edf8-4fad-93c2-deb6b23497f8carglumic acid 200 MG Tablet for Oral Suspension [PSN] · carglumic acid 200 MG Tablet for Oral Suspension [SCD] · carglumic acid 200 MG Dispersible Tablet for Oral Suspension [SY]33These highlights do not include all the information needed to use CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION. CARGLUMIC ACID tablets for oral suspension Initial U.S. Approval: 201020240323
2aee4281-402b-4cd6-9e6a-08945262e1a1carglumic acid 200 MG Tablet for Oral Suspension [PSN] · carglumic acid 200 MG Tablet for Oral Suspension [SCD] · carglumic acid 200 MG Dispersible Tablet for Oral Suspension [SY]32These highlights do not include all the information needed to use CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CARGLUMIC ACID TABLETS FOR ORAL SUSPENSION. CARGLUMIC ACID tablets for oral suspension Initial U.S. Approval: 201020240319