MONTELUKAST SODIUM
- Product NDC
- 72189-223
- 11-digit product format
- 721890223
- Labeler code
- 72189
- Product ID
- 72189-223_2c283d75-2454-ee48-e063-6294a90a7651
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST SODIUM
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA204093
- Marketing category
- ANDA
- Marketing start
- 2021-05-21
- Substance
- MONTELUKAST
- Active strength
- 5 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 |
|---|
| MHM278SD3E | MONTELUKAST | 158966-92-8 | MONTELUKAST |
| U1O3J18SFL | MONTELUKAST SODIUM | 151767-02-1 | MONTELUKAST SODIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-223-30 | 72189022330 | 30 TABLET, CHEWABLE in 1 BOTTLE (72189-223-30) | 2021-05-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| MONTELUKAST SODIUM | DIRECT RX | 2025-01-20 | HUMAN PRESCRIPTION DRUG LABEL | 2 |