Sertraline Hydrochloride
- Product NDC
- 80425-0310
- 11-digit product format
- 804250310
- Labeler code
- 80425
- Product ID
- 80425-0310_2a9bfe6a-6d6c-b262-e063-6294a90a1cf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2023-04-07
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0310-1 | 80425031001 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0310-1) | 2023-04-07 | No | No | Historical |
| 80425-0310-2 | 80425031002 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0310-2) | 2023-04-07 | No | No | Historical |
| 80425-0310-3 | 80425031003 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0310-3) | 2023-04-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline HCL Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |