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.

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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#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
482dcc92-b47f-4ea6-854a-f5ac2aea7842Singulair 4 MG (montelukast sodium 4.2 MG) Chewable TabletSY5These 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
482dcc92-b47f-4ea6-854a-f5ac2aea7842Singulair 4 MG Chewable TabletPSN5These 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
482dcc92-b47f-4ea6-854a-f5ac2aea7842Singulair 4 MG Chewable TabletSY5These 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
482dcc92-b47f-4ea6-854a-f5ac2aea7842montelukast 4 MG Chewable Tablet [Singulair]SBD5These 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 TabletSY1These 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
e8d9021d-73aa-4c96-8b8a-e90069e78555montelukast 4 MG Chewable Tablet [Singulair]SBD1These 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
e8d9021d-73aa-4c96-8b8a-e90069e78555Singulair 4 MG Chewable TabletPSN1These 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
e8d9021d-73aa-4c96-8b8a-e90069e78555Singulair 4 MG (montelukast sodium 4.2 MG) Chewable TabletSY1These 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