montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet
- RxCUI
- 242438
- RxNorm name
- montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet
- Display name
- montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet
- Full name
- montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet
- Term type
- SY
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:20
UNII Substances#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Montelukast Sodium | MONTELUKAST SODIUM | Torrent Pharmaceuticals Limited | da038cf6-cfad-43a4-ab8e-d81d028d6087 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 242438 |
| Montelukast Sodium | MONTELUKAST SODIUM | Rising Pharma Holdings, Inc. | 49669ac0-0bb5-4576-bed5-9e85e0d76a44 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 242438 |
| montelukast sodium | MONTELUKAST SODIUM | A-S Medication Solutions | 7ff11e37-9ea5-40b6-96f7-4caf27cab756 | 2026-03-07 | Boxed warning, Warnings, Adverse reactions | 242438 |
| montelukast sodium | MONTELUKAST SODIUM | A-S Medication Solutions | 1a312a28-8472-4cab-a7dd-d01cd8b2765a | 2026-03-07 | Boxed warning, Warnings, Adverse reactions | 242438 |
| montelukast sodium | MONTELUKAST SODIUM | Preferred Pharmaceuticals, Inc. | 09b0bc9e-3035-45b4-b61b-4aca70848360 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | 242438 |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Chartwell RX, LLC | 5cb4298c-10b1-4d6f-95ad-4aad72daf249 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 242438 |
| Montelukast Sodium | MONTELUKAST SODIUM | AvKARE | ed2caffa-a75c-1c27-ae30-2d8280eaea7d | 2025-12-16 | Warnings, Adverse reactions | 242438 |
| Montelukast Sodium | MONTELUKAST SODIUM | AvPAK | 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | 2025-10-29 | Warnings, Adverse reactions | 242438 |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Ajanta Pharma USA Inc. | 67070e4e-f755-46b3-b900-fcc1993a0546 | 2025-08-29 | Boxed warning, Warnings, Adverse reactions | 242438 |
| SINGULAIR | MONTELUKAST SODIUM | Organon LLC | 482dcc92-b47f-4ea6-854a-f5ac2aea7842 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | 242438 |
| Montelukast Sodium | MONTELUKAST | Amneal Pharmaceuticals LLC | bcd49102-a21c-4628-a322-6cdd934e7f09 | 2025-04-18 | Boxed warning, Warnings, Adverse reactions | 242438 |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | DIRECT RX | c2d834e6-7b38-d266-e053-2995a90a27ef | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | 242438 |
| Montelukast Sodium | MONTELUKAST SODIUM | Aurobindo Pharma Limited | ba42b0a9-83f1-4283-a853-f99cdd0761b9 | 2024-03-30 | Boxed warning, Warnings, Adverse reactions | 242438 |
| Montelukast Sodium | MONTELUKAST SODIUM | Lannett Company, Inc. | c43d1edb-c162-4317-9a89-d84e4eff5512 | 2023-07-11 | Boxed warning, Warnings, Adverse reactions | 242438 |
| Montelukast sodium | MONTELUKAST SODIUM | Macleods Pharmaceuticals Limited | ce512844-5220-4661-809f-56d088699c9c | 2023-07-06 | Boxed warning, Warnings, Adverse reactions | 242438 |
| montelukast sodium | MONTELUKAST SODIUM | Unichem Pharmaceuticals (USA), Inc. | 9e375c07-70db-458c-9336-22a7037b0a5f | 2023-06-12 | Boxed warning, Warnings, Adverse reactions | 242438 |
| Montelukast Sodium | MONTELUKAST SODIUM | Dr.Reddy's Laboratories Limited | 3d4451a9-d73d-b9de-68ec-853bfeff6e4b | 2022-10-30 | Boxed warning, Warnings, Adverse reactions | 242438 |
| montelukast sodium | MONTELUKAST SODIUM | Camber Pharmaceuticals, Inc. | 23964723-2df8-4d0a-a53d-8538469672f1 | 2021-06-18 | Boxed warning, Warnings, Adverse reactions | 242438 |
| MONTELUKAST | MONTELUKAST | Proficient Rx LP | 9705627c-283e-4743-b261-cfeb88d96e9b | 2019-11-01 | Warnings, Adverse reactions | 242438 |
| Montelukast Sodium | MONTELUKAST SODIUM | Proficient Rx LP | 0f2dbf17-bce0-4e09-8c22-898d93be80da | 2019-11-01 | Warnings, Adverse reactions | 242438 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| c43d1edb-c162-4317-9a89-d84e4eff5512 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 37 | These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE. MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | 20230711 |
| 3d4451a9-d73d-b9de-68ec-853bfeff6e4b | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 24 | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS . MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | 20221030 |
| da038cf6-cfad-43a4-ab8e-d81d028d6087 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 23 | These 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: 1998 | 20260306 |
| ed2caffa-a75c-1c27-ae30-2d8280eaea7d | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 22 | MONTELUKAST SODIUM TABLETS These 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: 1998 | 20251216 |
| ba42b0a9-83f1-4283-a853-f99cdd0761b9 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 21 | These 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: 1998 | 20240330 |
| 67070e4e-f755-46b3-b900-fcc1993a0546 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 20 | These 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: 1998 | 20250829 |
| bcd49102-a21c-4628-a322-6cdd934e7f09 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 20 | These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998 | 20250418 |
| 9e375c07-70db-458c-9336-22a7037b0a5f | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 17 | These 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: 1998 | 20230612 |
| 7ff11e37-9ea5-40b6-96f7-4caf27cab756 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 10 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | 20260307 |
| 49669ac0-0bb5-4576-bed5-9e85e0d76a44 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 10 | These 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: 1998 | 20240330 |
| 2f90a573-27fd-cc16-f3d1-8c4d630224a0 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 8 | MONTELUKAST SODIUM TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS Rx Only These 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: 1998 | 20251029 |
| ce512844-5220-4661-809f-56d088699c9c | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 8 | These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval 1998 | 20230706 |
| 09b0bc9e-3035-45b4-b61b-4aca70848360 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 6 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | 20260113 |
| 23964723-2df8-4d0a-a53d-8538469672f1 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 6 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | 20210618 |
| 482dcc92-b47f-4ea6-854a-f5ac2aea7842 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 5 | These 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: 1998 | 20250430 |
| 5cb4298c-10b1-4d6f-95ad-4aad72daf249 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 3 | Montelukast Sodium CHEWABLE Tablets, 4 mg and 5 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE. MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | 20251217 |
| 0f2dbf17-bce0-4e09-8c22-898d93be80da | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 3 | These 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 and Chewable Tablets, for oral use Initial U.S. Approval: 1998 | 20191101 |
| 9705627c-283e-4743-b261-cfeb88d96e9b | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998 | 20191101 |
| cab84c43-96a3-4868-88da-3126685edf00 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 3 | These 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, chewable tablets and oral granules Initial U.S. Approval: 1998 | 20191001 |
| 74dff97f-8cf4-48f0-a914-94ca033ac0e4 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 3 | These 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 and chewable tablets for oral use Initial U.S. Approval: 1998 | 20160806 |
| 43b80e54-bd48-46f0-835e-b055e797a8c0 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998 | 20150624 |
| c2d834e6-7b38-d266-e053-2995a90a27ef | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 2 | MONTELUKAST SODIUM | 20250120 |
| f4c0b28f-283c-7e04-e053-2a95a90aa39c | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 2 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | 20240807 |
| d16b5541-7366-4338-9ca4-06ce26be9619 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 2 | These 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: 1998 | 20211223 |
| b584f59e-2137-4786-8365-1e41e4c3c7db | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 2 | These 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: 1998 | 20211009 |
| 4be31c8e-81ea-11d2-e054-00144ff8d46c | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 2 | MONTELUKAST SODIUM | 20200121 |
| 2e207413-342a-4a7c-b9dd-881e6cd927cf | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | 20151112 |
| 09692f56-468c-4884-ae95-d2fb9d984e4c | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 2 | These 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 and chewable tablets for oral use Initial U.S. Approval: 1998 | 20120914 |
| 1a312a28-8472-4cab-a7dd-d01cd8b2765a | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 1 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998 | 20260307 |
| 12873921-cd30-4a8e-ba5e-45e4b0015001 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM tablets and MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998 | 20220809 |
| cf92d18d-02a9-4710-8b6c-65ac48dacf34 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 1 | These 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: 1998 | 20220330 |
| a8261a89-d35b-357e-e053-2a95a90afcd0 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 1 | These 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: 1998 | 20200615 |
| 147725da-4c8b-4608-87a9-053311d0aba0 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES. MONTELUKAST sodium tablets, chewable tablets Initial U.S. Approval: 1998 | 20180816 |
| d78d8e2d-2a80-4666-b1c2-73fc7ee7debf | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 1 | Warning Letter | 20171205 |
| e8d9021d-73aa-4c96-8b8a-e90069e78555 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 1 | These 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: 1998 | 20120216 |
| 78eea56d-15a6-4ceb-b755-d1a3e9707f32 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 1 | These 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: 1998 | 20101201 |
| 10cd5ca5-6f8b-417c-af11-a2054a2dde34 | montelukast sodium 5 MG Chewable Tablet [PSN] · montelukast 5 MG Chewable Tablet [SCD] · montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable Tablet [SY] | 3 | 1 | SINGULAIR® (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES | 20100301 |