montelukast sodium
- Product NDC
- 33261-969
- 11-digit product format
- 332610969
- Labeler code
- 33261
- Product ID
- 33261-969_733ee823-ddd2-45b5-9d27-44105e5bf34c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA090926
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- 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
- 2019-12-31
- 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 |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| montelukast sodium | Aidarex Pharmaceuticals LLC | 2014-01-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |