Paroxetine
- Product NDC
- 70518-0550
- 11-digit product format
- 705180550
- Labeler code
- 70518
- Product ID
- 70518-0550_e1e56f9d-26ea-5d3a-e053-2995a90aec21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2017-05-22
- 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
- 2023-12-31
- 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 |
|---|
| 70518-0550-0 | 70518055000 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0550-0) | 2017-05-22 | 0000-00-00 | No | No | Current |