Paroxetine
- Product NDC
- 72162-2358
- 11-digit product format
- 721622358
- Labeler code
- 72162
- Product ID
- 72162-2358_c6a22c4a-3353-418e-8cda-6cf6b46f3544
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- 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 |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2358-9 | 72162235809 | 90 TABLET, FILM COATED in 1 BOTTLE (72162-2358-9) | 2024-06-28 | No | No | Historical |