Montelukast Sodium
- Product NDC
- 0054-0259
- 11-digit product format
- 000540259
- Labeler code
- 0054
- Product ID
- 0054-0259_c91cde13-9b1f-402a-b1bd-920fedfade4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA090655
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- Marketing end
- 2021-02-28
- 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
- 0000-00-00
- 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 |
|---|
| 0054-0259-22 | 00054025922 | 90 TABLET in 1 BOTTLE (0054-0259-22) | 90 tablet | 2012-08-03 | 2021-02-28 | No | No | Current |