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#
| Label | Generic name | Manufacturer | SPL set ID | Effective date | Safety fields | Match |
|---|---|---|---|---|---|---|
| Montelukast | MONTELUKAST | A-S Medication Solutions | 6741830f-5d90-4066-bc3b-065059bc150d | 2023-11-02 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Bryant Ranch Prepack | 4ba27278-6249-4546-9331-b19302cbf2db | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Proficient Rx LP | 07d5fbea-b183-41c9-a20f-30da1f44ab1b | 2023-10-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Lannett Company, Inc. | c43d1edb-c162-4317-9a89-d84e4eff5512 | 2023-07-11 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast sodium | MONTELUKAST SODIUM | Macleods Pharmaceuticals Limited | ce512844-5220-4661-809f-56d088699c9c | 2023-07-06 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | Unichem Pharmaceuticals (USA), Inc. | 9e375c07-70db-458c-9336-22a7037b0a5f | 2023-06-12 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Aurobindo Pharma Limited | 9a3bfc59-0ca6-4433-abf5-41659bfe0a8f | 2023-06-03 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Proficient Rx LP | 461f2aaa-e091-478e-97c1-27a089db8cdc | 2023-03-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | Macleods Pharmaceuticals Limited | e0c5b856-3f70-4ca6-9763-a90673bb82fb | 2023-01-21 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | XLCare Pharmaceuticals Inc. | 82d65eea-c7c9-4e16-9176-46c43f00f0f6 | 2023-01-17 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Dr.Reddy's Laboratories Limited | 3d4451a9-d73d-b9de-68ec-853bfeff6e4b | 2022-10-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | Proficient Rx LP | 2ce48faf-4504-488a-8b20-3e8d4f008fb2 | 2022-06-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Proficient Rx LP | 97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5 | 2022-05-02 | Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | BluePoint Laboratories | 4c411d3e-47b6-481b-b846-419ed4cbb947 | 2022-03-10 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Accord Healthcare Inc. | 6eea668f-a2fa-447f-b2d5-4c754d13d9fa | 2022-01-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Proficient Rx LP | 83c35a3d-0bbc-4598-bf76-ab0c2903bf19 | 2021-07-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | Aphena Pharma Solutions - Tennessee, LLC | 4fe3c0d4-94ff-43ca-9d24-54676fe593fe | 2021-06-26 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | Camber Pharmaceuticals, Inc. | 23964723-2df8-4d0a-a53d-8538469672f1 | 2021-06-18 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Proficient Rx LP | 901385e5-7384-4c28-a36a-7dd84c36f5fd | 2021-01-01 | Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Proficient Rx LP | 54014b67-3163-4c8f-b93a-229cd231ca6b | 2021-01-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Proficient Rx LP | 8a724790-e1fb-4935-bb28-ce99455be5ef | 2019-11-01 | Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST | MONTELUKAST | Proficient Rx LP | 9705627c-283e-4743-b261-cfeb88d96e9b | 2019-11-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Proficient Rx LP | 0f2dbf17-bce0-4e09-8c22-898d93be80da | 2019-11-01 | Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST SODIUM | MONTELUKAST | Proficient Rx LP | cab84c43-96a3-4868-88da-3126685edf00 | 2019-10-01 | Warnings, Adverse reactions | Name/manufacturer search |
| SINGULAIR | MONTELUKAST SODIUM | Organon LLC | 482dcc92-b47f-4ea6-854a-f5ac2aea7842 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |