Paroxetine Hydrochloride
- Product NDC
- 0378-2005
- 11-digit product format
- 003782005
- Labeler code
- 0378
- Product ID
- 0378-2005_c0e82152-59ec-4ca4-8d1a-883ad52f98bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA091427
- Marketing category
- ANDA
- Marketing start
- 2011-05-05
- Marketing end
- 2021-11-30
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 38 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 0378-2005-93 | 00378200593 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2005-93) | 2011-05-05 | 0000-00-00 | No | No | Current |