Paroxetine
- Product NDC
- 52817-143
- 11-digit product format
- 528170143
- Labeler code
- 52817
- Product ID
- 52817-143_c99bdd4e-f632-460b-b2e3-af37995cf220
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Trupharma, LLC
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2016-09-30
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 40 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52817-143-50 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-b98f-f424-e053-dadaa90a57ce | dbfba12f-7ec9-40bf-b15b-57d759f2cf68 |
| 52817-143-90 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-b98f-f424-e053-dadaa90a57ce | dbfba12f-7ec9-40bf-b15b-57d759f2cf68 |
| 52817-143-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b98f-f424-e053-dadaa90a57ce | dbfba12f-7ec9-40bf-b15b-57d759f2cf68 |
| 52817-143-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b98f-f424-e053-dadaa90a57ce | dbfba12f-7ec9-40bf-b15b-57d759f2cf68 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52817-143-50 | EA - Each | 52817-143 | 7591d0c3-45a4-4474-83e2-00403f7cc1d2 | 1 | 2017-03-06 |
| 52817-143-90 | EA - Each | 52817-143 | 139bd5c7-1cfe-4e6d-964e-393e7d73c0c6 | 1 | 2017-03-06 |