Montelukast sodium
- Product NDC
- 58657-717
- 11-digit product format
- 586570717
- Labeler code
- 58657
- Product ID
- 58657-717_edb4a6c4-7868-74a6-e053-2a95a90ae685
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA209012
- Marketing category
- ANDA
- Marketing start
- 2022-01-21
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58657-717-30 | 58657071730 | 30 TABLET in 1 BOTTLE (58657-717-30) | 30 tablet | 2022-01-21 | 0000-00-00 | No | No | Current |
| 58657-717-90 | 58657071790 | 90 TABLET in 1 BOTTLE (58657-717-90) | 90 tablet | 2022-01-21 | 0000-00-00 | No | No | Current |