Paroxetine
- Product NDC
- 71205-198
- 11-digit product format
- 712050198
- Labeler code
- 71205
- Product ID
- 71205-198_077517cd-4eee-4524-997c-fecc919b72c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- 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 |
|---|
| 71205-198-30 | 71205019830 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-198-30) | 2019-01-01 | No | No | Historical |
| 71205-198-90 | 71205019890 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-198-90) | 2019-01-01 | No | No | Historical |