Paroxetine
- Product NDC
- 62135-425
- 11-digit product format
- 621350425
- Labeler code
- 62135
- Product ID
- 62135-425_efb6b453-333a-211d-e053-2995a90ae2d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA204744
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 12.5 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 |
|---|
| 41VRH5220H | PAROXETINE | 61869-08-7 | Paroxetine |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-425-30 | 62135042530 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-425-30) | 2022-12-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Paroxetine | Chartwell RX, LLC | 2022-12-13 | HUMAN PRESCRIPTION DRUG LABEL | 1 |