Montelukast Sodium
- Product NDC
- 68788-8610
- 11-digit product format
- 687888610
- Labeler code
- 68788
- Product ID
- 68788-8610_4770cc7d-0fd7-4992-bd3e-f59c54cbd3b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA201515
- Marketing category
- ANDA
- Marketing start
- 2024-03-20
- Substance
- MONTELUKAST SODIUM
- Active strength
- 10 mg/1
- Pharmacologic classes
- Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| U1O3J18SFL | MONTELUKAST SODIUM | 151767-02-1 | MONTELUKAST SODIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8610-3 | 68788861003 | 30 TABLET in 1 BOTTLE (68788-8610-3) | 30 tablet | 2024-03-20 | No | No | Historical |
| 68788-8610-6 | 68788861006 | 60 TABLET in 1 BOTTLE (68788-8610-6) | 60 tablet | 2024-03-20 | No | No | Historical |
| 68788-8610-9 | 68788861009 | 90 TABLET in 1 BOTTLE (68788-8610-9) | 90 tablet | 2024-03-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Montelukast Sodium | Preferred Pharmaceuticals Inc. | 2025-08-13 | HUMAN PRESCRIPTION DRUG LABEL | 2 |