Paroxetine
- Product NDC
- 68788-7677
- 11-digit product format
- 687887677
- Labeler code
- 68788
- Product ID
- 68788-7677_6be7827f-270e-4cf6-803d-0dccd8fbf263
- 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
- 2020-03-02
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7677-1 | 68788767701 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-7677-1) | 2020-03-02 | 0000-00-00 | No | No | Current |
| 68788-7677-3 | 68788767703 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7677-3) | 2020-03-02 | 0000-00-00 | No | No | Current |
| 68788-7677-6 | 68788767706 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7677-6) | 2020-03-02 | 0000-00-00 | No | No | Current |
| 68788-7677-8 | 68788767708 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-7677-8) | 2020-03-02 | 0000-00-00 | No | No | Current |
| 68788-7677-9 | 68788767709 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7677-9) | 2020-03-02 | 0000-00-00 | No | No | Current |