PAROXETINE
- Product NDC
- 70518-3613
- 11-digit product format
- 705183613
- Labeler code
- 70518
- Product ID
- 70518-3613_f1d8c7f1-90d2-94e8-e053-2a95a90af57f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PAROXETINE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204134
- Marketing category
- ANDA
- Marketing start
- 2023-01-09
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- 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 |
|---|
| 70518-3613-0 | 70518361300 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3613-0) | 2023-01-09 | 0000-00-00 | No | No | Current |