Sertraline
- Product NDC
- 60760-683
- 11-digit product format
- 607600683
- Labeler code
- 60760
- Product ID
- 60760-683_3dd832b1-cef3-e200-e063-6294a90a8ec3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA076465
- Marketing category
- ANDA
- Marketing start
- 2023-02-23
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 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 |
| QUC7NX6WMB | SERTRALINE | 79617-96-2 | Sertraline |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60760-683-90 | 60760068390 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-683-90) | 2025-09-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline | ST. MARY'S MEDICAL PARK PHARMACY | 2025-09-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |