MONTELUKAST
- Product NDC
- 68788-7387
- 11-digit product format
- 687887387
- Labeler code
- 68788
- Product ID
- 68788-7387_cadcb051-95ee-4793-8ee6-40f85dd71ec7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA203037
- Marketing category
- ANDA
- Marketing start
- 2016-09-13
- 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