FDA.reportPublic FDA data

montelukast sodium 4 MG Oral Granules

RxCUI
351246
RxNorm name
montelukast sodium 4 MG Oral Granules
Display name
montelukast sodium 4 MG Oral Granules
Full name
montelukast sodium 4 MG Oral Granules
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Montelukast SodiumMONTELUKAST SODIUMTorrent Pharmaceuticals Limitedda038cf6-cfad-43a4-ab8e-d81d028d60872026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351246
MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma USA Inc.67070e4e-f755-46b3-b900-fcc1993a05462025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351246
SINGULAIRMONTELUKAST SODIUMOrganon LLC482dcc92-b47f-4ea6-854a-f5ac2aea78422025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351246
Montelukast SodiumMONTELUKAST SODIUMAurobindo Pharma Limited9a3bfc59-0ca6-4433-abf5-41659bfe0a8f2023-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351246

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
da038cf6-cfad-43a4-ab8e-d81d028d6087montelukast sodium 4 MG Oral Granules [PSN] · montelukast 4 MG Oral Granules [SCD] · montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules [SY]323These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM oral granules Initial U.S. Approval: 199820260306
67070e4e-f755-46b3-b900-fcc1993a0546montelukast sodium 4 MG Oral Granules [PSN] · montelukast 4 MG Oral Granules [SCD] · montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules [SY]320These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM oral granules Initial U.S. Approval: 199820250829
3d3df874-d710-7fa4-bb21-434977518337montelukast sodium 4 MG Oral Granules [PSN] · montelukast 4 MG Oral Granules [SCD] · montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules [SY]315These highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES . MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 199820190830
9a3bfc59-0ca6-4433-abf5-41659bfe0a8fmontelukast sodium 4 MG Oral Granules [PSN] · montelukast 4 MG Oral Granules [SCD] · montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules [SY]38These highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES. MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 199820230603
482dcc92-b47f-4ea6-854a-f5ac2aea7842montelukast sodium 4 MG Oral Granules [PSN] · montelukast 4 MG Oral Granules [SCD] · montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules [SY]35These 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