Sertraline Hydrochloride
- Product NDC
- 76420-781
- 11-digit product format
- 764200781
- Labeler code
- 76420
- Product ID
- 76420-781_2dffc9e0-9a6b-2d51-e063-6294a90ac7be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- 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 |
|---|
| 76420-781-01 | 76420078101 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-781-01) | 2024-03-14 | No | No | Historical |
| 76420-781-30 | 76420078130 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-781-30) | 2024-03-14 | No | No | Historical |
| 76420-781-60 | 76420078160 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-781-60) | 2024-03-14 | No | No | Historical |
| 76420-781-90 | 76420078190 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-781-90) | 2024-03-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline Hydrochloride | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-02-12 | HUMAN PRESCRIPTION DRUG LABEL | 2 |