Paroxetine
- Product NDC
- 80425-0339
- 11-digit product format
- 804250339
- Labeler code
- 80425
- Product ID
- 80425-0339_2a9bf7d3-46dd-0dfa-e063-6394a90a76a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2023-05-19
- 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 |
| 41VRH5220H | PAROXETINE | 61869-08-7 | Paroxetine |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0339-1 | 80425033901 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0339-1) | 2023-05-19 | No | No | Historical |
| 80425-0339-2 | 80425033902 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0339-2) | 2023-05-19 | No | No | Historical |
| 80425-0339-3 | 80425033903 | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0339-3) | 2023-05-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Paroxetine Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |