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#

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 · 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: 153892

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
482dcc92-b47f-4ea6-854a-f5ac2aea7842Singulair 10 MG Oral Tablet [PSN] · montelukast 10 MG Oral Tablet [Singulair] [SBD] · Singulair 10 MG (montelukast sodium 10.4 MG) Oral Tablet [SY] · Singulair 10 MG Oral 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 10 MG Oral Tablet [PSN] · montelukast 10 MG Oral Tablet [Singulair] [SBD] · Singulair 10 MG (montelukast sodium 10.4 MG) Oral Tablet [SY] · Singulair 10 MG Oral 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
78eea56d-15a6-4ceb-b755-d1a3e9707f32Singulair 10 MG Oral Tablet [PSN] · montelukast 10 MG Oral Tablet [Singulair] [SBD] · Singulair 10 MG (montelukast sodium 10.4 MG) Oral Tablet [SY] · Singulair 10 MG Oral 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: 199820101201
10cd5ca5-6f8b-417c-af11-a2054a2dde34Singulair 10 MG Oral Tablet [PSN] · montelukast 10 MG Oral Tablet [Singulair] [SBD] · Singulair 10 MG (montelukast sodium 10.4 MG) Oral Tablet [SY] · Singulair 10 MG Oral Tablet [SY]41SINGULAIR® (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES20100301