montelukast sodium
- Product NDC
- 68788-7771
- 11-digit product format
- 687887771
- Labeler code
- 68788
- Product ID
- 68788-7771_fc1d0567-9524-43c8-929d-fd093936abc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- montelukast sodium
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA204093
- Marketing category
- ANDA
- Marketing start
- 2020-08-03
- Marketing end
- 0000-00-00
- Substance
- MONTELUKAST
- Active strength
- 4 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 |
|---|
| 68788-7771 | MONTELUKAST SODIUM TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC.] | 5 | Legacy NDC | 20240724_4351bd67-99df-4327-b98d-bf23cc989904.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7771-1 | 68788777101 | 10 TABLET, CHEWABLE in 1 BOTTLE (68788-7771-1) | 2020-08-03 | 0000-00-00 | No | No | Current |
| 68788-7771-2 | 68788777102 | 20 TABLET, CHEWABLE in 1 BOTTLE (68788-7771-2) | 2020-08-03 | 0000-00-00 | No | No | Current |
| 68788-7771-3 | 68788777103 | 30 TABLET, CHEWABLE in 1 BOTTLE (68788-7771-3) | 2020-08-03 | 0000-00-00 | No | No | Current |
| 68788-7771-4 | 68788777104 | 14 TABLET, CHEWABLE in 1 BOTTLE (68788-7771-4) | 2020-08-03 | 0000-00-00 | No | No | Current |
| 68788-7771-6 | 68788777106 | 60 TABLET, CHEWABLE in 1 BOTTLE (68788-7771-6) | 2020-08-03 | 0000-00-00 | No | No | Current |
| 68788-7771-9 | 68788777109 | 90 TABLET, CHEWABLE in 1 BOTTLE (68788-7771-9) | 2020-08-03 | 0000-00-00 | No | No | Current |