Sertraline Hydrochloride
- Product NDC
- 53002-3215
- 11-digit product format
- 530023215
- Labeler code
- 53002
- Product ID
- 53002-3215_684bc9dd-0438-4984-9d47-a5c9a3b24462
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077206
- Marketing category
- ANDA
- Marketing start
- 2007-02-06
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- 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 |
|---|
| 53002-3215-0 | 53002321500 | 100 TABLET, FILM COATED in 1 BOTTLE (53002-3215-0) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-3215-3 | 53002321503 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-3215-3) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-3215-6 | 53002321506 | 60 TABLET, FILM COATED in 1 BOTTLE (53002-3215-6) | 2019-01-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Sertraline Hydrochloride | RPK Pharmaceuticals, Inc. | 2023-06-07 | Human Prescription Drug Label | 3 |