Paroxetine
- Product NDC
- 49999-828
- 11-digit product format
- 499990828
- Labeler code
- 49999
- Product ID
- 49999-828_f261b7f8-57d6-4113-a46e-cc4ef18b2930
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2007-04-13
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record