paroxetine hydrochloride
- Product NDC
- 71335-9650
- 11-digit product format
- 713359650
- Labeler code
- 71335
- Product ID
- 71335-9650_52e74299-f193-408d-9d0d-e48398a1734a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076968
- Marketing category
- ANDA
- Marketing start
- 2022-11-14
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 30 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 |
|---|
| 71335-9650-1 | 71335965001 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9650-1) | 2023-03-28 | No | No | Historical |
| 71335-9650-2 | 71335965002 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9650-2) | 2024-09-06 | No | No | Historical |
| 71335-9650-3 | 71335965003 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9650-3) | 2024-09-06 | No | No | Historical |
| 71335-9650-4 | 71335965004 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-9650-4) | 2024-09-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| paroxetine hydrochloride | Bryant Ranch Prepack | 2024-09-06 | HUMAN PRESCRIPTION DRUG LABEL | 102 |