FDA.reportPublic FDA data

montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet

RxCUI
200224
RxNorm name
montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet
Display name
montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet
Full name
montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MontelukastMONTELUKASTCoupler LLC583a9499-97f0-2ebf-e063-6394a90a35af2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
Montelukast SodiumMONTELUKAST SODIUMTorrent Pharmaceuticals Limitedda038cf6-cfad-43a4-ab8e-d81d028d60872026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
montelukast sodiumMONTELUKAST SODIUMPreferred Pharmaceuticals Inc.1eeb3123-9e93-4681-8096-800a7c7acf8a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
MontelukastMONTELUKASTPreferred Pharmaceuticals, Inc.94642db1-5c75-44c4-92b4-8385b486df822026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
Montelukast SodiumMONTELUKAST SODIUMPreferred Pharmaceuticals Inc.64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
Montelukast SodiumMONTELUKAST SODIUMRising Pharma Holdings, Inc.49669ac0-0bb5-4576-bed5-9e85e0d76a442026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
MontelukastMONTELUKASTREMEDYREPACK INC.ecaa9b4b-5941-4af5-930c-35e9f3b2b4ba2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
MontelukastMONTELUKASTAvPAKd7870c45-5a8b-8369-e053-2a95a90ae1f32026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
Montelukast SodiumMONTELUKAST SODIUMRedpharm Drug2fbdf1be-a37f-879b-e063-6394a90aa20d2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
Montelukast SodiumMONTELUKAST SODIUMAvKAREed2caffa-a75c-1c27-ae30-2d8280eaea7d2025-12-16Warnings, Adverse reactionsExact identifier
rxcui: 200224
MONTELUKASTMONTELUKAST SODIUMA-S Medication Solutionsda9821f1-536a-416b-9594-210bde0cefaf2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
Montelukast SodiumMONTELUKAST SODIUMAvPAK2f90a573-27fd-cc16-f3d1-8c4d630224a02025-10-29Warnings, Adverse reactionsExact identifier
rxcui: 200224
Montelukast SodiumMONTELUKAST SODIUMPD-Rx Pharmaceuticals, Inc.c9ec1996-6a54-4622-b8a6-57dea49f6b352025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
Montelukast SodiumMONTELUKAST SODIUMPD-Rx Pharmaceuticals, Inc.6ffff72c-8784-477b-8722-5434a19881a02025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma USA Inc.67070e4e-f755-46b3-b900-fcc1993a05462025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
Montelukast SodiumMONTELUKAST SODIUMMajor Pharmaceuticalsa4dc63cf-8145-42f4-9437-93b414d2aed42025-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
MontelukastMONTELUKASTSandoz Inc6d69e73a-76cb-4ece-9cf9-e9adb4f523b42025-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
MontelukastMONTELUKASTNuCare Pharmaceuticals, Inc.365e1c5c-01b2-bf4e-e063-6394a90a0e432025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
SINGULAIRMONTELUKAST SODIUMOrganon LLC482dcc92-b47f-4ea6-854a-f5ac2aea78422025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224
MONTELUKAST SODIUMMONTELUKAST SODIUMCamber Pharmaceuticals, Inc.97a682c2-7e00-4d07-a5ac-4436c977f8422025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 200224

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 3 of 3 · 83 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ea764c40-6647-3f9f-e053-2a95a90a4239montelukast sodium 10 MG Oral Tablet [PSN] · montelukast 10 MG Oral Tablet [SCD] · montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet [SY]31These 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 Initial U.S. Approval: 199820221007
f3f3ee81-2530-402f-9c0a-c828fda2ca1fmontelukast sodium 10 MG Oral Tablet [PSN] · montelukast 10 MG Oral Tablet [SCD] · montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet [SY]31These highlights do not include all the information needed to use montelukast sodium tablets safely and effectively. See full prescribing information for montelukast sodium tablets. Montelukast Sodium Tablets Initial U.S. Approval: 199820140115
e8d9021d-73aa-4c96-8b8a-e90069e78555montelukast sodium 10 MG Oral Tablet [PSN] · montelukast 10 MG Oral Tablet [SCD] · montelukast 10 MG (as montelukast sodium 10.4 MG) Oral Tablet [SY]31These 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