Montelukast Sodium
- Product NDC
- 71335-0301
- 11-digit product format
- 713350301
- Labeler code
- 71335
- Product ID
- 71335-0301_666271bf-7405-4609-9573-266d911b6bbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090984
- 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
- 2021-12-31
- 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 |
|---|
| 71335-0301-1 | 71335030101 | 30 TABLET, CHEWABLE in 1 BOTTLE (71335-0301-1) | 2014-04-18 | 0000-00-00 | No | No | Current |
| 71335-0301-2 | 71335030102 | 90 TABLET, CHEWABLE in 1 BOTTLE (71335-0301-2) | 2014-04-18 | 0000-00-00 | No | No | Current |
| 71335-0301-3 | 71335030103 | 60 TABLET, CHEWABLE in 1 BOTTLE (71335-0301-3) | 2014-04-18 | 0000-00-00 | No | No | Current |
| 71335-0301-4 | 71335030104 | 28 TABLET, CHEWABLE in 1 BOTTLE (71335-0301-4) | 2014-04-18 | 0000-00-00 | No | No | Current |