FDA.reportPublic FDA data

montelukast 10 MG Oral Tablet [Singulair]

RxCUI
153892
RxNorm name
montelukast 10 MG Oral Tablet [Singulair]
Display name
montelukast 10 MG Oral Tablet [Singulair]
Full name
montelukast 10 MG Oral Tablet [Singulair]
Term type
SBD
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: 153892

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
482dcc92-b47f-4ea6-854a-f5ac2aea7842montelukast 10 MG Oral 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
482dcc92-b47f-4ea6-854a-f5ac2aea7842Singulair 10 MG (montelukast sodium 10.4 MG) Oral 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 10 MG Oral 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 10 MG Oral 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
e8d9021d-73aa-4c96-8b8a-e90069e78555Singulair 10 MG (montelukast sodium 10.4 MG) Oral 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-e90069e78555Singulair 10 MG Oral 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 10 MG Oral 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 10 MG Oral 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
78eea56d-15a6-4ceb-b755-d1a3e9707f32montelukast 10 MG Oral 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: 199820101201
78eea56d-15a6-4ceb-b755-d1a3e9707f32Singulair 10 MG Oral 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: 199820101201
78eea56d-15a6-4ceb-b755-d1a3e9707f32Singulair 10 MG (montelukast sodium 10.4 MG) Oral 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: 199820101201
78eea56d-15a6-4ceb-b755-d1a3e9707f32Singulair 10 MG Oral 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: 199820101201
10cd5ca5-6f8b-417c-af11-a2054a2dde34montelukast 10 MG Oral Tablet [Singulair]SBD1SINGULAIR® (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES20100301
10cd5ca5-6f8b-417c-af11-a2054a2dde34Singulair 10 MG Oral TabletPSN1SINGULAIR® (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES20100301
10cd5ca5-6f8b-417c-af11-a2054a2dde34Singulair 10 MG (montelukast sodium 10.4 MG) Oral TabletSY1SINGULAIR® (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES20100301
10cd5ca5-6f8b-417c-af11-a2054a2dde34Singulair 10 MG Oral TabletSY1SINGULAIR® (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES20100301