montelukast sodium
- Product NDC
- 71335-1602
- 11-digit product format
- 713351602
- Labeler code
- 71335
- Product ID
- 71335-1602_640b5606-8295-4f8d-9929-aedf2f51d227
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204093
- Marketing category
- ANDA
- Marketing start
- 2015-05-27
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1602-1 | 71335160201 | 30 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-1) | 2020-05-13 | No | No | Historical |
| 71335-1602-2 | 71335160202 | 90 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-2) | 2020-05-13 | No | No | Historical |
| 71335-1602-3 | 71335160203 | 60 TABLET, CHEWABLE in 1 BOTTLE (71335-1602-3) | 2022-02-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| montelukast sodium | Bryant Ranch Prepack | 2024-10-07 | HUMAN PRESCRIPTION DRUG LABEL | 5 |