MONTELUKAST
- Product NDC
- 69452-105
- 11-digit product format
- 694520105
- Labeler code
- 69452
- Product ID
- 69452-105_d44af51c-2284-0c9a-e053-2995a90a7bcd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MONTELUKAST
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA202859
- Marketing category
- ANDA
- Marketing start
- 2014-12-01
- Marketing end
- 2021-12-31
- Substance
- MONTELUKAST SODIUM
- Active strength
- 10 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 |
|---|
| 69452-105-13 | 69452010513 | 30 TABLET, FILM COATED in 1 BOTTLE (69452-105-13) | 2014-12-01 | 0000-00-00 | No | No | Current |
| 69452-105-19 | 69452010519 | 90 TABLET, FILM COATED in 1 BOTTLE (69452-105-19) | 2014-12-01 | 0000-00-00 | No | No | Current |
| 69452-105-32 | 69452010532 | 1000 TABLET, FILM COATED in 1 BOTTLE (69452-105-32) | 2014-12-01 | 0000-00-00 | No | No | Current |