Paroxetine
- Product NDC
- 63187-564
- 11-digit product format
- 631870564
- Labeler code
- 63187
- Product ID
- 63187-564_4637d56c-fd38-47ea-b814-4d87a7d36f1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078406
- Marketing category
- ANDA
- Marketing start
- 2009-12-03
- 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 |
|---|
| 63187-564-30 | 63187056430 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-564-30) | 2018-12-01 | No | No | Historical |
| 63187-564-60 | 63187056460 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-564-60) | 2018-12-01 | No | No | Historical |
| 63187-564-90 | 63187056490 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-564-90) | 2018-12-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Paroxetine Tablets, USP | Proficient Rx LP | 2021-01-01 | HUMAN PRESCRIPTION DRUG LABEL | 3 |