SERTRALINE HYDROCHLORIDE
- Product NDC
- 68071-2496
- 11-digit product format
- 680712496
- Labeler code
- 68071
- Product ID
- 68071-2496_c8e6dec4-64b3-560e-e053-2995a90a915e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SERTRALINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA202825
- Marketing category
- ANDA
- Marketing start
- 2017-02-09
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2496-9 | 68071249609 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-2496-9) | 2021-08-06 | 0000-00-00 | No | No | Current |