Sertraline hydrochloride
- Product NDC
- 50090-7395
- 11-digit product format
- 500907395
- Labeler code
- 50090
- Product ID
- 50090-7395_7e6058fe-fd67-4178-81db-fc63e88b573b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078403
- Marketing category
- ANDA
- Marketing start
- 2023-05-15
- 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 |
|---|
| 50090-7395-0 | 50090739500 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7395-0) | 2024-10-23 | No | No | Historical |
| 50090-7395-1 | 50090739501 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7395-1) | 2024-10-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline hydrochloride | A-S Medication Solutions | 2024-10-25 | HUMAN PRESCRIPTION DRUG LABEL | 1 |