FDA.reportPublic FDA data

Singulair 4 MG Oral Granules

RxCUI
404406
RxNorm name
Singulair 4 MG Oral Granules
Display name
Singulair 4 MG Oral Granules
Full name
Singulair 4 MG Oral Granules
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: 404406

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
482dcc92-b47f-4ea6-854a-f5ac2aea7842Singulair 4 MG Oral Granules [PSN] · montelukast 4 MG Oral Granules [Singulair] [SBD] · Singulair 4 MG (montelukast sodium 4.2 MG) Oral Granules [SY] · Singulair 4 MG Oral Granules [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