Sertraline hydrochloride
- Product NDC
- 68788-8689
- 11-digit product format
- 687888689
- Labeler code
- 68788
- Product ID
- 68788-8689_d5e9ac54-19cd-41c6-8677-8ae955b24b27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078403
- Marketing category
- ANDA
- Marketing start
- 2024-06-06
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| UTI8907Y6X | SERTRALINE HYDROCHLORIDE | 79559-97-0 | SERTRALINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8689-1 | 68788868901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8689-1) | 2024-06-06 | No | No | Historical |
| 68788-8689-3 | 68788868903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8689-3) | 2024-06-06 | No | No | Historical |
| 68788-8689-6 | 68788868906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8689-6) | 2024-06-06 | No | No | Historical |
| 68788-8689-9 | 68788868909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8689-9) | 2024-06-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline hydrochloride | Preferred Pharmaceuticals Inc. | 2025-09-18 | HUMAN PRESCRIPTION DRUG LABEL | 2 |