Sertraline hydrochloride
- Product NDC
- 60760-988
- 11-digit product format
- 607600988
- Labeler code
- 60760
- Product ID
- 60760-988_51cbab52-0fcc-ad79-e063-6394a90a0bc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA078403
- Marketing category
- ANDA
- Marketing start
- 2024-08-15
- 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
- 2027-12-31
- 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 |
|---|
| 60760-988-90 | 60760098890 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-988-90) | 2024-08-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline hydrochloride | ST. MARY'S MEDICAL PARK PHARMACY | 2026-05-14 | HUMAN PRESCRIPTION DRUG LABEL | 3 |