SINGULAIR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Organon Llc. The primary component is Montelukast Sodium.
| Product ID | 78206-172_44fce13e-2484-4ea6-9995-2e2b68331c29 |
| NDC | 78206-172 |
| Product Type | Human Prescription Drug |
| Proprietary Name | SINGULAIR |
| Generic Name | Montelukast Sodium |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-06-01 |
| Marketing Category | NDA / |
| Application Number | NDA020829 |
| Labeler Name | Organon LLC |
| Substance Name | MONTELUKAST SODIUM |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0006-1711 | SINGULAIR | montelukast sodium |
| 0006-3841 | SINGULAIR | montelukast sodium |
| 0006-9117 | SINGULAIR | montelukast sodium |
| 0006-9275 | SINGULAIR | montelukast sodium |
| 68258-3033 | SINGULAIR | SINGULAIR |
| 68258-3032 | SINGULAIR | SINGULAIR |
| 21695-221 | SINGULAIR | SINGULAIR |
| 21695-565 | SINGULAIR | SINGULAIR |
| 63629-2979 | SINGULAIR | SINGULAIR |
| 63629-3701 | SINGULAIR | SINGULAIR |
| 0054-0259 | Montelukast Sodium | Montelukast Sodium |
| 0054-0288 | Montelukast Sodium | Montelukast Sodium |
| 0054-0289 | Montelukast Sodium | Montelukast Sodium |
| 0093-7424 | Montelukast Sodium | Montelukast Sodium |
| 0093-7425 | Montelukast Sodium | Montelukast Sodium |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SINGULAIR 74589438 2048127 Live/Registered |
MERCK SHARP & DOHME CORP. 1994-10-24 |
![]() SINGULAIR 73793956 1570791 Live/Registered |
NORWALK WASTEWATER EQUIPMENT COMPANY 1989-04-17 |