montelukast sodium 4 MG Oral Granules
- RxCUI
- 351246
- RxNorm name
- montelukast sodium 4 MG Oral Granules
- Display name
- montelukast sodium 4 MG Oral Granules
- Full name
- montelukast sodium 4 MG Oral Granules
- Term type
- PSN
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:23
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 | 351246 |
| MONTELUKAST SODIUM | MONTELUKAST SODIUM | Ajanta Pharma USA Inc. | 67070e4e-f755-46b3-b900-fcc1993a0546 | 2025-08-29 | Boxed warning, Warnings, Adverse reactions | 351246 |
| SINGULAIR | MONTELUKAST SODIUM | Organon LLC | 482dcc92-b47f-4ea6-854a-f5ac2aea7842 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | 351246 |
| Montelukast Sodium | MONTELUKAST SODIUM | Aurobindo Pharma Limited | 9a3bfc59-0ca6-4433-abf5-41659bfe0a8f | 2023-06-03 | Boxed warning, Warnings, Adverse reactions | 351246 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| da038cf6-cfad-43a4-ab8e-d81d028d6087 | montelukast 4 MG Oral Granules | SCD | 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 |
| da038cf6-cfad-43a4-ab8e-d81d028d6087 | montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules | SY | 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 |
| da038cf6-cfad-43a4-ab8e-d81d028d6087 | montelukast sodium 4 MG Oral Granules | PSN | 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 |
| 67070e4e-f755-46b3-b900-fcc1993a0546 | montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules | SY | 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 |
| 67070e4e-f755-46b3-b900-fcc1993a0546 | montelukast 4 MG Oral Granules | SCD | 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 |
| 67070e4e-f755-46b3-b900-fcc1993a0546 | montelukast sodium 4 MG Oral Granules | PSN | 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 |
| 3d3df874-d710-7fa4-bb21-434977518337 | montelukast 4 MG Oral Granules | SCD | 15 | These highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES . MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 1998 | 20190830 |
| 3d3df874-d710-7fa4-bb21-434977518337 | montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules | SY | 15 | These highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES . MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 1998 | 20190830 |
| 3d3df874-d710-7fa4-bb21-434977518337 | montelukast sodium 4 MG Oral Granules | PSN | 15 | These highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES . MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 1998 | 20190830 |
| 9a3bfc59-0ca6-4433-abf5-41659bfe0a8f | montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules | SY | 8 | These highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES. MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 1998 | 20230603 |
| 9a3bfc59-0ca6-4433-abf5-41659bfe0a8f | montelukast sodium 4 MG Oral Granules | PSN | 8 | These highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES. MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 1998 | 20230603 |
| 9a3bfc59-0ca6-4433-abf5-41659bfe0a8f | montelukast 4 MG Oral Granules | SCD | 8 | These highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES. MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 1998 | 20230603 |
| 482dcc92-b47f-4ea6-854a-f5ac2aea7842 | montelukast 4 MG (as montelukast sodium 4.2 MG) Oral Granules | SY | 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 |
| 482dcc92-b47f-4ea6-854a-f5ac2aea7842 | montelukast 4 MG Oral Granules | SCD | 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 |
| 482dcc92-b47f-4ea6-854a-f5ac2aea7842 | montelukast sodium 4 MG Oral Granules | PSN | 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 |