Montelukast Sodium
- Product NDC
- 63629-8106
- 11-digit product format
- 636298106
- Labeler code
- 63629
- Product ID
- 63629-8106_b8b86f2b-1fe3-4a58-9bf4-e826166609c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202717
- Marketing category
- ANDA
- Marketing start
- 2013-04-11
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8106-1 | 63629810601 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-8106-1) | 2019-07-25 | 0000-00-00 | No | No | Current |
| 63629-8106-2 | 63629810602 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-8106-2) | 2019-07-25 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Montelukast Sodium | Bryant Ranch Prepack | 2021-12-23 | HUMAN PRESCRIPTION DRUG LABEL | 2 |