Montelukast Sodium
- Product NDC
- 68788-7064
- 11-digit product format
- 687887064
- Labeler code
- 68788
- Product ID
- 68788-7064_de79b9f2-a511-4e63-8395-a371fb2e6b56
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- {Preferred Pharmaeutials INC.
- Application
- ANDA090984
- Marketing category
- ANDA
- Marketing start
- 2018-01-05
- 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 |
|---|
| 68788-7064-1 | 68788706401 | 10 TABLET, CHEWABLE in 1 BOTTLE (68788-7064-1) | 2018-01-05 | 0000-00-00 | No | No | Current |
| 68788-7064-2 | 68788706402 | 20 TABLET, CHEWABLE in 1 BOTTLE (68788-7064-2) | 2018-01-05 | 0000-00-00 | No | No | Current |
| 68788-7064-3 | 68788706403 | 30 TABLET, CHEWABLE in 1 BOTTLE (68788-7064-3) | 2018-01-05 | 0000-00-00 | No | No | Current |
| 68788-7064-4 | 68788706404 | 14 TABLET, CHEWABLE in 1 CARTON (68788-7064-4) | 2018-01-05 | 0000-00-00 | No | No | Current |
| 68788-7064-6 | 68788706406 | 60 TABLET, CHEWABLE in 1 BOTTLE (68788-7064-6) | 2018-01-05 | 0000-00-00 | No | No | Current |
| 68788-7064-9 | 68788706409 | 90 TABLET, CHEWABLE in 1 BOTTLE (68788-7064-9) | 2018-01-05 | 0000-00-00 | No | No | Current |