Sertraline
- Product NDC
- 68071-3626
- 11-digit product format
- 680713626
- Labeler code
- 68071
- Product ID
- 68071-3626_1ac8a634-8ac6-aac7-e063-6294a90a240a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077670
- 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 |
| QUC7NX6WMB | SERTRALINE | 79617-96-2 | Sertraline |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3626-3 | 68071362603 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3626-3) | 2024-06-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline | NuCare Pharmaceuticals,Inc. | 2024-06-13 | HUMAN PRESCRIPTION DRUG LABEL | 1 |