Montelukast Sodium
- Product NDC
- 71205-778
- 11-digit product format
- 712050778
- Labeler code
- 71205
- Product ID
- 71205-778_461f2aaa-e091-478e-97c1-27a089db8cdc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202468
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-778-30 | 71205077830 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-778-30) | 2023-03-21 | No | No | Historical |
| 71205-778-60 | 71205077860 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-778-60) | 2023-03-21 | No | No | Historical |
| 71205-778-90 | 71205077890 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-778-90) | 2023-03-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Montelukast Sodium | Proficient Rx LP | 2023-03-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |