Montelukast Sodium
- Product NDC
- 59651-329
- 11-digit product format
- 596510329
- Labeler code
- 59651
- Product ID
- 59651-329_2fcb1880-c88e-4c82-829e-6177a07814c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA213471
- Marketing category
- ANDA
- Marketing start
- 2020-02-18
- Substance
- MONTELUKAST SODIUM
- Active strength
- 4 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-329-30 | 59651032930 | 30 PACKET in 1 CARTON (59651-329-30) / 1 GRANULE in 1 PACKET (59651-329-05) | 30 packet | 2020-02-18 | No | No | Historical |