Montelukast Sodium
- Product NDC
- 50090-5403
- 11-digit product format
- 500905403
- Labeler code
- 50090
- Product ID
- 50090-5403_67d75630-d117-425a-b17e-83ddf933bce5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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
- 2022-12-31
- 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 |
|---|
| 50090-5403-0 | 50090540300 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5403-0) | 2020-12-08 | 0000-00-00 | No | No | Current |