Sertraline Hydrochloride
- Product NDC
- 68788-4045
- 11-digit product format
- 687884045
- Labeler code
- 68788
- Product ID
- 68788-4045_8f5a71b2-2821-46a0-ac65-28d9b2db73ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2025-10-17
- 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 |
|---|
| 68788-4045-1 | 68788404501 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-4045-1) | 2025-10-17 | No | No | Historical |
| 68788-4045-3 | 68788404503 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4045-3) | 2025-10-17 | No | No | Historical |
| 68788-4045-6 | 68788404506 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4045-6) | 2025-10-17 | No | No | Historical |
| 68788-4045-9 | 68788404509 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-4045-9) | 2025-10-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline Hydrochloride | Preferred Pharmaceuticals Inc. | 2025-10-17 | HUMAN PRESCRIPTION DRUG LABEL | 1 |