Paroxetine
- Product NDC
- 43353-554
- 11-digit product format
- 433530554
- Labeler code
- 43353
- Product ID
- 43353-554_37d67ac2-1470-43aa-a06d-b24981539fd4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078902
- Marketing category
- ANDA
- Marketing start
- 2008-03-24
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 20 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 |
|---|
| 43353-554-15 | 43353055415 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-554-15) | 2009-11-05 | No | No | Historical |
| 43353-554-30 | 43353055430 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-554-30) | 2019-02-01 | No | No | Historical |
| 43353-554-45 | 43353055445 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-554-45) | 2014-08-07 | No | No | Historical |