SERTRALINE HYDROCHLORIDE
- Product NDC
- 50090-7693
- 11-digit product format
- 500907693
- Labeler code
- 50090
- Product ID
- 50090-7693_5dbdb645-4666-4bd0-a49a-beacb026cd9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sertraline hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA214790
- Marketing category
- ANDA
- Marketing start
- 2021-05-03
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7693-0 | 50090769300 | 30 TABLET in 1 BOTTLE (50090-7693-0) | 30 tablet | 2025-10-10 | No | No | Historical |
| 50090-7693-1 | 50090769301 | 60 TABLET in 1 BOTTLE (50090-7693-1) | 60 tablet | 2025-10-10 | No | No | Historical |
| 50090-7693-2 | 50090769302 | 90 TABLET in 1 BOTTLE (50090-7693-2) | 90 tablet | 2025-10-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SERTRALINE HYDROCHLORIDE | A-S Medication Solutions | 2025-10-14 | HUMAN PRESCRIPTION DRUG LABEL | 1 |