FDA.reportPublic FDA data

metaxalone 400 MG Oral Tablet

RxCUI
197935
RxNorm name
metaxalone 400 MG Oral Tablet
Display name
metaxalone 400 MG Oral Tablet
Full name
metaxalone 400 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:24

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetaxaloneMETAXALONEHighmark Pharma LLC834be129-cfb5-4420-b660-025833376b3e2026-04-29Warnings, Adverse reactionsExact identifier
rxcui: 197935
MetaxaloneMETAXALONEAmneal Pharmaceuticals of New York LLCde3448df-4ca1-44ec-bad1-486549cddf642024-08-30Warnings, Adverse reactionsExact identifier
rxcui: 197935
MetaxaloneMETAXALONEScieGen Pharmaceuticals, Inc.1cef46bb-e590-4a58-82e0-7cf1fc3836a52024-08-21Warnings, Adverse reactionsExact identifier
rxcui: 197935
MetaxaloneMETAXALONEMisemer Pharmaceuticals, Inc.d0276e7b-a1c9-61f3-e053-2a95a90ae3aa2024-02-01Warnings, Adverse reactionsExact identifier
rxcui: 197935
MetaxaloneMETAXALONECIPLA USA INC.c1f49112-e8ce-43a9-bdb8-1a3db4fb6bc42023-06-08Warnings, Adverse reactionsExact identifier
rxcui: 197935

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
de3448df-4ca1-44ec-bad1-486549cddf64metaxalone 400 MG Oral TabletSCD9These highlights do not include all the information needed to use METAXALONE TABLETS safely and effectively. See full prescribing information for METAXALONE TABLETS . METAXALONE tablets, for oral use Initial U.S. Approval: 196220240830
de3448df-4ca1-44ec-bad1-486549cddf64metaxalone 400 MG Oral TabletPSN9These highlights do not include all the information needed to use METAXALONE TABLETS safely and effectively. See full prescribing information for METAXALONE TABLETS . METAXALONE tablets, for oral use Initial U.S. Approval: 196220240830
1cef46bb-e590-4a58-82e0-7cf1fc3836a5metaxalone 400 MG Oral TabletSCD2These highlights do not include all the information needed to use METAXALONE TABLETS safely and effectively. See full prescribing information for METAXALONE TABLETS. METAXALONE tablets, for oral use Initial U.S. Approval: 196220240821
1cef46bb-e590-4a58-82e0-7cf1fc3836a5metaxalone 400 MG Oral TabletPSN2These highlights do not include all the information needed to use METAXALONE TABLETS safely and effectively. See full prescribing information for METAXALONE TABLETS. METAXALONE tablets, for oral use Initial U.S. Approval: 196220240821
d0276e7b-a1c9-61f3-e053-2a95a90ae3aametaxalone 400 MG Oral TabletSCD2METAXALONE TABLETS, USP20240201
d0276e7b-a1c9-61f3-e053-2a95a90ae3aametaxalone 400 MG Oral TabletPSN2METAXALONE TABLETS, USP20240201
834be129-cfb5-4420-b660-025833376b3emetaxalone 400 MG Oral TabletPSN1METAXALONE TABLETS, USP20260429
834be129-cfb5-4420-b660-025833376b3emetaxalone 400 MG Oral TabletSCD1METAXALONE TABLETS, USP20260429
c1f49112-e8ce-43a9-bdb8-1a3db4fb6bc4metaxalone 400 MG Oral TabletSCD1METAXALONE TABLETS, USP20230608
c1f49112-e8ce-43a9-bdb8-1a3db4fb6bc4metaxalone 400 MG Oral TabletPSN1METAXALONE TABLETS, USP20230608
168c539d-3637-4a43-a8b6-cd8e82cf6342metaxalone 400 MG Oral TabletSCD1METAXALONE TABLETS, USP20200603
168c539d-3637-4a43-a8b6-cd8e82cf6342metaxalone 400 MG Oral TabletPSN1METAXALONE TABLETS, USP20200603