Sertraline
- Product NDC
- 68788-7329
- 11-digit product format
- 687887329
- Labeler code
- 68788
- Product ID
- 68788-7329_9d4a88c2-e79d-45b2-a9ab-2f789c2862bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA077670
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| UTI8907Y6X | SERTRALINE HYDROCHLORIDE | 79559-97-0 | SERTRALINE HYDROCHLORIDE |
| QUC7NX6WMB | SERTRALINE | 79617-96-2 | Sertraline |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7329-1 | 68788732901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-7329-1) | 2019-10-25 | 0000-00-00 | No | No | Current |
| 68788-7329-2 | 68788732902 | 28 TABLET, FILM COATED in 1 BOTTLE (68788-7329-2) | 2019-10-25 | 0000-00-00 | No | No | Current |
| 68788-7329-3 | 68788732903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7329-3) | 2019-10-25 | 0000-00-00 | No | No | Current |
| 68788-7329-6 | 68788732906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7329-6) | 2019-10-25 | 0000-00-00 | No | No | Current |
| 68788-7329-8 | 68788732908 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-7329-8) | 2019-10-25 | 0000-00-00 | No | No | Current |
| 68788-7329-9 | 68788732909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7329-9) | 2019-10-25 | 0000-00-00 | No | No | Current |