MONTELUKAST
- Product NDC
- 69452-107
- 11-digit product format
- 694520107
- Labeler code
- 69452
- Product ID
- 69452-107_d44af51c-2284-0c9a-e053-2995a90a7bcd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA203037
- Marketing category
- ANDA
- Marketing start
- 2014-12-01
- Marketing end
- 2021-12-31
- 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
- 0000-00-00
- 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 |
|---|
| 69452-107-13 | 69452010713 | 30 TABLET, CHEWABLE in 1 BOTTLE (69452-107-13) | 2014-12-01 | 0000-00-00 | No | No | Current |
| 69452-107-19 | 69452010719 | 90 TABLET, CHEWABLE in 1 BOTTLE (69452-107-19) | 2014-12-01 | 0000-00-00 | No | No | Current |
| 69452-107-32 | 69452010732 | 1000 TABLET, CHEWABLE in 1 BOTTLE (69452-107-32) | 2014-12-01 | 0000-00-00 | No | No | Current |