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 Sodium | MONTELUKAST SODIUM | Torrent Pharmaceuticals Limited | da038cf6-cfad-43a4-ab8e-d81d028d6087 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | Preferred Pharmaceuticals Inc. | 1eeb3123-9e93-4681-8096-800a7c7acf8a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | Preferred Pharmaceuticals, Inc. | 94642db1-5c75-44c4-92b4-8385b486df82 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Preferred Pharmaceuticals Inc. | 64a3b181-e8d8-4caf-9f1b-e0063d0bd94a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Rising Pharma Holdings, Inc. | 49669ac0-0bb5-4576-bed5-9e85e0d76a44 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | PD-Rx Pharmaceuticals, Inc. | c69ab399-8ea6-4002-9271-b6a57c862b14 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | REMEDYREPACK INC. | ecaa9b4b-5941-4af5-930c-35e9f3b2b4ba | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | A-S Medication Solutions | 7ff11e37-9ea5-40b6-96f7-4caf27cab756 | 2026-03-07 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | A-S Medication Solutions | 1a312a28-8472-4cab-a7dd-d01cd8b2765a | 2026-03-07 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | A-S Medication Solutions | 25b2049d-3a93-4ac3-8de6-14f5d7ce0315 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | A-S Medication Solutions | 04b3faff-1ea1-4d2a-aa31-9d6e742e1759 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | Preferred Pharmaceuticals, Inc. | 09b0bc9e-3035-45b4-b61b-4aca70848360 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | AvPAK | d7870c45-5a8b-8369-e053-2a95a90ae1f3 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Redpharm Drug | 2fbdf1be-a37f-879b-e063-6394a90aa20d | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Chartwell RX, LLC | 5cb4298c-10b1-4d6f-95ad-4aad72daf249 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | AvKARE | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 2025-12-16 | Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST | MONTELUKAST SODIUM | A-S Medication Solutions | da9821f1-536a-416b-9594-210bde0cefaf | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | AvPAK | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 2025-10-29 | Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | PD-Rx Pharmaceuticals, Inc. | c9ec1996-6a54-4622-b8a6-57dea49f6b35 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | PD-Rx Pharmaceuticals, Inc. | 6ffff72c-8784-477b-8722-5434a19881a0 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST | Amneal Pharmaceuticals LLC | ccbbf0d6-efd9-4fdd-9e7b-e3d293062609 | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Ajanta Pharma USA Inc. | 67070e4e-f755-46b3-b900-fcc1993a0546 | 2025-08-29 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Cardinal Health 107, LLC | 9287d2f1-2414-4ee2-aecc-b6b59c6a0a4c | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | Major Pharmaceuticals | a4dc63cf-8145-42f4-9437-93b414d2aed4 | 2025-06-19 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | Sandoz Inc | 6d69e73a-76cb-4ece-9cf9-e9adb4f523b4 | 2025-06-13 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | NuCare Pharmaceuticals, Inc. | 365e1c5c-01b2-bf4e-e063-6394a90a0e43 | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST | Amneal Pharmaceuticals LLC | bcd49102-a21c-4628-a322-6cdd934e7f09 | 2025-04-18 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Camber Pharmaceuticals, Inc. | 97a682c2-7e00-4d07-a5ac-4436c977f842 | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | Quallent Pharmaceuticals Health LLC | 5d71088b-b0fa-4bf0-a6e7-6163bd9e0dd4 | 2025-02-28 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Direct_Rx | f3bdf2a3-d661-5128-e053-2995a90a4661 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | DIRECT RX | c2d834e6-7b38-d266-e053-2995a90a27ef | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | NuCare Pharmaceuticals,Inc. | a7c11cbe-0834-27a5-e053-2995a90ac43f | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | American Health Packaging | fb1b2e4e-a840-447b-b943-ad0b6acc32b5 | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | Bryant Ranch Prepack | 3ff4100f-11e3-4d6a-ab88-83bd605a1818 | 2024-10-07 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | Bryant Ranch Prepack | 6b26218d-52a6-4109-90e4-412a17d14fcf | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Rising Pharma Holdings, Inc. | 75723c5a-3c9e-468a-bc65-57b4c755889a | 2024-07-26 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | NuCare Pharmaceuticals,Inc. | 566a8fd7-fc00-2297-e054-00144ff8d46c | 2024-07-17 | Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast | MONTELUKAST | NuCare Pharmaceuticals,Inc. | 56429f04-97b6-06a9-e054-00144ff88e88 | 2024-07-17 | Warnings, Adverse reactions | Name/manufacturer search |
| Montelukast Sodium | MONTELUKAST SODIUM | NuCare Pharmaceuticals,Inc. | 549f1d1a-81f5-29f5-e054-00144ff8d46c | 2024-07-10 | Warnings, Adverse reactions | Name/manufacturer search |
| montelukast sodium | MONTELUKAST SODIUM | Bryant Ranch Prepack | 9beb1510-f3af-4269-a9d0-e2bd41ac369b | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |