Sertraline
- Product NDC
- 68645-589
- 11-digit product format
- 686450589
- Labeler code
- 68645
- Product ID
- 68645-589_a13784bb-95fc-47e8-9f5d-b52f47cfddb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA077670
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Marketing end
- 2022-10-31
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 68645-589-54 | 68645058954 | 30 TABLET, FILM COATED in 1 BOTTLE (68645-589-54) | 2007-02-06 | 2022-10-31 | No | No | Current |