Montelukast Sodium
- Product NDC
- 0054-0289
- 11-digit product format
- 000540289
- Labeler code
- 0054
- Product ID
- 0054-0289_97860b50-e95b-4960-82be-916d9d4ba16a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA091128
- Marketing category
- ANDA
- Marketing start
- 2012-08-03
- Marketing end
- 0000-00-00
- Substance
- MONTELUKAST SODIUM
- Active strength
- 5 mg/1
- Pharmacologic classes
- Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 0054-0289-13 | 00054028913 | 30 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-13) | 2012-08-03 | 0000-00-00 | No | No | Current |
| 0054-0289-22 | 00054028922 | 90 TABLET, CHEWABLE in 1 BOTTLE (0054-0289-22) | 2012-08-03 | 0000-00-00 | No | No | Current |