Montelukast Sodium
- Product NDC
- 43063-762
- 11-digit product format
- 430630762
- Labeler code
- 43063
- Product ID
- 43063-762_414b7ce2-7550-5e40-e063-6294a90afda2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA202717
- Marketing category
- ANDA
- Marketing start
- 2013-04-11
- 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 |
|---|
| 43063-762-30 | 43063076230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-762-30) | 2017-05-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Montelukast Sodium | PD-Rx Pharmaceuticals, Inc. | 2025-10-16 | HUMAN PRESCRIPTION DRUG LABEL | 22 |
| Montelukast Sodium | PD-Rx Pharmaceuticals, Inc. | 2024-10-14 | HUMAN PRESCRIPTION DRUG LABEL | 21 |