Paroxetine
- Product NDC
- 71610-056
- 11-digit product format
- 716100056
- Labeler code
- 71610
- Product ID
- 71610-056_dc77c275-c420-46bc-863a-cfe7ef2881be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078406
- Marketing category
- ANDA
- Marketing start
- 2009-12-03
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- 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 |
| 41VRH5220H | PAROXETINE | 61869-08-7 | Paroxetine |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-056-15 | 71610005615 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-056-15) | 2018-05-02 | No | No | Historical |
| 71610-056-45 | 71610005645 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-056-45) | 2018-05-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Paroxetine Tablets, USP | Aphena Pharma Solutions - Tennessee, LLC | 2018-05-08 | Human Prescription Drug Label | 1 |