SERTRALINE HYDROCHLORIDE
- Product NDC
- 71610-433
- 11-digit product format
- 716100433
- Labeler code
- 71610
- Product ID
- 71610-433_7c2f1809-97f9-4942-a4f0-5fe016dd709a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sertraline hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA019839
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-08-12
- 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
- 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 |
|---|
| 71610-433-15 | 71610043315 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-433-15) | 2020-06-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SERTRALINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 2020-06-19 | HUMAN PRESCRIPTION DRUG LABEL | 1 |