FDA.reportPublic FDA data

Singulair 4 MG (montelukast sodium 4.2 MG) Chewable Tablet

RxCUI
261367
RxNorm name
Singulair 4 MG (montelukast sodium 4.2 MG) Chewable Tablet
Display name
Singulair 4 MG (montelukast sodium 4.2 MG) Chewable Tablet
Full name
Singulair 4 MG (montelukast sodium 4.2 MG) Chewable Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

RxNav Current And Historical NDCs#

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UNII Substances#

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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
SINGULAIRMONTELUKAST SODIUMOrganon LLC482dcc92-b47f-4ea6-854a-f5ac2aea78422025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 261367

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
482dcc92-b47f-4ea6-854a-f5ac2aea7842Singulair 4 MG Chewable Tablet [PSN] · montelukast 4 MG Chewable Tablet [Singulair] [SBD] · Singulair 4 MG (montelukast sodium 4.2 MG) Chewable Tablet [SY] · Singulair 4 MG Chewable Tablet [SY]45These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR ® (montelukast sodium) tablets, for oral use SINGULAIR ® (montelukast sodium) chewable tablets, for oral use SINGULAIR ® (montelukast sodium) oral granules Initial U.S. Approval: 199820250430
e8d9021d-73aa-4c96-8b8a-e90069e78555Singulair 4 MG Chewable Tablet [PSN] · montelukast 4 MG Chewable Tablet [Singulair] [SBD] · Singulair 4 MG (montelukast sodium 4.2 MG) Chewable Tablet [SY] · Singulair 4 MG Chewable Tablet [SY]41These highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR ® (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules Initial U.S. Approval: 199820120216