Paroxetine
- Product NDC
- 43353-845
- 11-digit product format
- 433530845
- Labeler code
- 43353
- Product ID
- 43353-845_773d481a-a489-492b-a74e-eede0e3987da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078406
- Marketing category
- ANDA
- Marketing start
- 2007-07-25
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-845 | PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC | 20171026_5e5a999b-45a8-4d98-bf08-c040fbfda067.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-845-15 | 43353084515 | 15 TABLET, FILM COATED in 1 BOTTLE (43353-845-15) | 2017-07-26 | 0000-00-00 | No | No | Current |
| 43353-845-45 | 43353084545 | 45 TABLET, FILM COATED in 1 BOTTLE (43353-845-45) | 2017-08-08 | 0000-00-00 | No | No | Current |