Montelukast Sodium
- Product NDC
- 68788-9438
- 11-digit product format
- 687889438
- Labeler code
- 68788
- Product ID
- 68788-9438_83e555c5-e380-4f2d-95ef-d406a902eed1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Montelukast Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202717
- Marketing category
- ANDA
- Marketing start
- 2016-06-17
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9438 | MONTELUKAST SODIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 9 | Legacy NDC | 20240724_8ae3f1fc-4bc1-4412-96d0-deb7eed74c08.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-9438-1 | 68788943801 | 10 TABLET, FILM COATED in 1 BOTTLE (68788-9438-1) | 2016-06-17 | 0000-00-00 | No | No | Current |
| 68788-9438-2 | 68788943802 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-9438-2) | 2016-06-17 | 0000-00-00 | No | No | Current |
| 68788-9438-3 | 68788943803 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-9438-3) | 2016-06-17 | 0000-00-00 | No | No | Current |
| 68788-9438-4 | 68788943804 | 14 TABLET, FILM COATED in 1 BOTTLE (68788-9438-4) | 2016-06-17 | 0000-00-00 | No | No | Current |
| 68788-9438-6 | 68788943806 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-9438-6) | 2016-06-17 | 0000-00-00 | No | No | Current |
| 68788-9438-9 | 68788943809 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-9438-9) | 2016-06-17 | 0000-00-00 | No | No | Current |