Sertraline hydrochloride
- Product NDC
- 67046-1483
- 11-digit product format
- 670461483
- Labeler code
- 67046
- Product ID
- 67046-1483_2ce04fcc-4bad-22dc-e063-6294a90af8a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA078403
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- 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 |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1483-3 | 67046148303 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1483-3) | 2025-01-29 | No | No | Historical |