Montelukast Sodium
- Product NDC
- 52343-036
- 11-digit product format
- 523430036
- Labeler code
- 52343
- Product ID
- 52343-036_8ca2556d-1268-471b-b5b7-fc59bdf49f8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- ACETRIS HEALTH, LLC
- Application
- ANDA202096
- 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
- 2020-12-31
- 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 |
|---|
| 52343-036-05 | 52343003605 | 500 TABLET, CHEWABLE in 1 BOTTLE (52343-036-05) | 2012-08-03 | 0000-00-00 | No | No | Current |
| 52343-036-30 | 52343003630 | 30 TABLET, CHEWABLE in 1 BOTTLE (52343-036-30) | 2012-08-03 | 0000-00-00 | No | No | Current |
| 52343-036-90 | 52343003690 | 90 TABLET, CHEWABLE in 1 BOTTLE (52343-036-90) | 2012-08-03 | 0000-00-00 | No | No | Current |