Montelukast Sodium
- Product NDC
- 58657-715
- 11-digit product format
- 586570715
- Labeler code
- 58657
- Product ID
- 58657-715_eda16625-5dc3-c17e-e053-2a95a90a089a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA209011
- Marketing category
- ANDA
- Marketing start
- 2022-01-14
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58657-715-30 | 58657071530 | 30 TABLET, CHEWABLE in 1 BOTTLE (58657-715-30) | 2022-01-14 | 0000-00-00 | No | No | Current |
| 58657-715-90 | 58657071590 | 90 TABLET, CHEWABLE in 1 BOTTLE (58657-715-90) | 2022-01-14 | 0000-00-00 | No | No | Current |