Montelukast
- Product NDC
- 50090-6109
- 11-digit product format
- 500906109
- Labeler code
- 50090
- Product ID
- 50090-6109_b1ddd118-1dcd-475c-986b-20a2c1536eaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202843
- Marketing category
- ANDA
- Marketing start
- 2014-09-10
- 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 |
| MHM278SD3E | MONTELUKAST | 158966-92-8 | Montelukast |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6109-0 | 50090610900 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6109-0) | 2022-09-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Montelukast | A-S Medication Solutions | 2023-12-11 | HUMAN PRESCRIPTION DRUG LABEL | 1 |