Paroxetine
- Product NDC
- 55289-053
- 11-digit product format
- 552890053
- Labeler code
- 55289
- Product ID
- 55289-053_34663b6d-d8b7-08ea-e063-6294a90a6358
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078902
- Marketing category
- ANDA
- Marketing start
- 2008-03-24
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 40 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 |
|---|
| X2ELS050D8 | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 110429-35-1 | paroxetine hydrochloride hemihydrate |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55289-053-45 | 55289005345 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-45) | 2011-04-01 | No | No | Historical |
| 55289-053-90 | 55289005390 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-90) | 2011-04-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Paroxetine | PD-Rx Pharmaceuticals, Inc. | 2025-05-05 | HUMAN PRESCRIPTION DRUG LABEL | 22 |