FDA labels

Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.

Label matches#

FDA label search results page 1 of 2 · 50 matching rows.

Label, Generic name, Manufacturer table
LabelGeneric nameManufacturerSPL set IDEffective dateSafety fieldsMatch
Montelukast SodiumMONTELUKAST SODIUMTorrent Pharmaceuticals Limitedda038cf6-cfad-43a4-ab8e-d81d028d60872026-07-28Boxed warning, Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMPreferred Pharmaceuticals Inc.1eeb3123-9e93-4681-8096-800a7c7acf8a2026-07-28Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMPreferred Pharmaceuticals Inc.64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2026-07-28Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMRising Pharma Holdings, Inc.49669ac0-0bb5-4576-bed5-9e85e0d76a442026-05-29Boxed warning, Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions7ff11e37-9ea5-40b6-96f7-4caf27cab7562026-03-07Boxed warning, Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions1a312a28-8472-4cab-a7dd-d01cd8b2765a2026-03-07Boxed warning, Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions25b2049d-3a93-4ac3-8de6-14f5d7ce03152026-03-05Boxed warning, Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions04b3faff-1ea1-4d2a-aa31-9d6e742e17592026-03-05Boxed warning, Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMPreferred Pharmaceuticals, Inc.09b0bc9e-3035-45b4-b61b-4aca708483602026-01-13Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMRedpharm Drug2fbdf1be-a37f-879b-e063-6394a90aa20d2025-12-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search
MONTELUKAST SODIUMMONTELUKAST SODIUMChartwell RX, LLC5cb4298c-10b1-4d6f-95ad-4aad72daf2492025-12-17Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMAvKAREed2caffa-a75c-1c27-ae30-2d8280eaea7d2025-12-16Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMAvPAK2f90a573-27fd-cc16-f3d1-8c4d630224a02025-10-29Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMPD-Rx Pharmaceuticals, Inc.c9ec1996-6a54-4622-b8a6-57dea49f6b352025-10-16Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMPD-Rx Pharmaceuticals, Inc.6ffff72c-8784-477b-8722-5434a19881a02025-10-09Boxed warning, Warnings, Adverse reactionsName/manufacturer search
MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma USA Inc.67070e4e-f755-46b3-b900-fcc1993a05462025-08-29Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMMajor Pharmaceuticalsa4dc63cf-8145-42f4-9437-93b414d2aed42025-06-19Boxed warning, Warnings, Adverse reactionsName/manufacturer search
MONTELUKAST SODIUMMONTELUKAST SODIUMCamber Pharmaceuticals, Inc.97a682c2-7e00-4d07-a5ac-4436c977f8422025-03-13Boxed warning, Warnings, Adverse reactionsName/manufacturer search
MONTELUKAST SODIUMMONTELUKAST SODIUMDirect_Rxf3bdf2a3-d661-5128-e053-2995a90a46612025-01-22Boxed warning, Warnings, Adverse reactionsName/manufacturer search
MONTELUKAST SODIUMMONTELUKAST SODIUMDIRECT RXc2d834e6-7b38-d266-e053-2995a90a27ef2025-01-20Boxed warning, Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMNuCare Pharmaceuticals,Inc.a7c11cbe-0834-27a5-e053-2995a90ac43f2024-12-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMAmerican Health Packagingfb1b2e4e-a840-447b-b943-ad0b6acc32b52024-10-31Boxed warning, Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMBryant Ranch Prepack3ff4100f-11e3-4d6a-ab88-83bd605a18182024-10-07Boxed warning, Warnings, Adverse reactionsName/manufacturer search
MONTELUKAST SODIUMMONTELUKAST SODIUMRising Pharma Holdings, Inc.75723c5a-3c9e-468a-bc65-57b4c755889a2024-07-26Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMNuCare Pharmaceuticals,Inc.566a8fd7-fc00-2297-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMNuCare Pharmaceuticals,Inc.549f1d1a-81f5-29f5-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMBryant Ranch Prepack9beb1510-f3af-4269-a9d0-e2bd41ac369b2024-04-03Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMAurobindo Pharma Limitedba42b0a9-83f1-4283-a853-f99cdd0761b92024-03-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMWestminster Pharmaceuticals, LLCc0daaaf3-6717-4a01-e053-2995a90af2d82024-01-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMBryant Ranch Prepack4ba27278-6249-4546-9331-b19302cbf2db2023-11-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMProficient Rx LP07d5fbea-b183-41c9-a20f-30da1f44ab1b2023-10-01Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMLannett Company, Inc.c43d1edb-c162-4317-9a89-d84e4eff55122023-07-11Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast sodiumMONTELUKAST SODIUMMacleods Pharmaceuticals Limitedce512844-5220-4661-809f-56d088699c9c2023-07-06Boxed warning, Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMUnichem Pharmaceuticals (USA), Inc.9e375c07-70db-458c-9336-22a7037b0a5f2023-06-12Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMAurobindo Pharma Limited9a3bfc59-0ca6-4433-abf5-41659bfe0a8f2023-06-03Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMProficient Rx LP461f2aaa-e091-478e-97c1-27a089db8cdc2023-03-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMDr.Reddy's Laboratories Limited3d4451a9-d73d-b9de-68ec-853bfeff6e4b2022-10-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search
montelukast sodiumMONTELUKAST SODIUMProficient Rx LP2ce48faf-4504-488a-8b20-3e8d4f008fb22022-06-01Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMProficient Rx LP97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e52022-05-02Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMAccord Healthcare Inc.6eea668f-a2fa-447f-b2d5-4c754d13d9fa2022-01-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search