Paroxetine
- Product NDC
- 68788-8829
- 11-digit product format
- 687888829
- Labeler code
- 68788
- Product ID
- 68788-8829_91c5a321-e174-4d86-9a84-e5e278d45aff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2025-02-13
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 10 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
openFDA Listing Details
- Product ID
- 68788-8829_91c5a321-e174-4d86-9a84-e5e278d45aff
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Paroxetine
- Generic name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2025-02-13
- Marketing category
- ANDA
- Application number
- ANDA203854
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]; Serotonin Uptake Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738483 |
| Spl Set Id | 91c5a321-e174-4d86-9a84-e5e278d45aff |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
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 |
|---|
| 68788-8829-1 | 68788882901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8829-1) | 2025-02-13 | No | No | Current |
| 68788-8829-3 | 68788882903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8829-3) | 2025-02-13 | No | No | Current |
| 68788-8829-6 | 68788882906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8829-6) | 2025-02-13 | No | No | Current |
| 68788-8829-8 | 68788882908 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8829-8) | 2025-02-13 | No | No | Current |
| 68788-8829-9 | 68788882909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8829-9) | 2025-02-13 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Paroxetine | Preferred Pharmaceuticals Inc. | 2025-02-13 | HUMAN PRESCRIPTION DRUG LABEL | 1 |