montelukast sodium
- Product NDC
- 68001-248
- 11-digit product format
- 680010248
- Labeler code
- 68001
- Product ID
- 68001-248_99487683-63d4-27f1-e053-2a95a90aa0b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA090926
- Marketing category
- ANDA
- Marketing start
- 2014-03-13
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- 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 |
|---|
| 68001-248-03 | 68001024803 | 500 TABLET, FILM COATED in 1 BOTTLE (68001-248-03) | 2014-03-13 | 0000-00-00 | No | No | Current |
| 68001-248-04 | 68001024804 | 30 TABLET, FILM COATED in 1 BOTTLE (68001-248-04) | 2014-03-13 | 0000-00-00 | No | No | Current |
| 68001-248-05 | 68001024805 | 90 TABLET, FILM COATED in 1 BOTTLE (68001-248-05) | 2014-03-13 | 0000-00-00 | No | No | Current |