Paroxetine
- Product NDC
- 68071-3278
- 11-digit product format
- 680713278
- Labeler code
- 68071
- Product ID
- 68071-3278_51674ad0-4ca0-5b02-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2016-09-30
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 20 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-3278-3 | 2024-08-30 | C162847 | 48780-1 | 9d75b9d0-5fbf-f424-e053-dadaa90a57ce | 51674ad0-4c9f-5b02-e054-00144ff88e88 |
| 68071-3278-6 | 2024-08-30 | C162847 | 48780-1 | 9d75b9d0-5fbf-f424-e053-dadaa90a57ce | 51674ad0-4c9f-5b02-e054-00144ff88e88 |
| 68071-3278-9 | 2024-08-30 | C162847 | 48780-1 | 9d75b9d0-5fbf-f424-e053-dadaa90a57ce | 51674ad0-4c9f-5b02-e054-00144ff88e88 |
| 68071-3278-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5fbf-f424-e053-dadaa90a57ce | 51674ad0-4c9f-5b02-e054-00144ff88e88 |
| 68071-3278-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5fbf-f424-e053-dadaa90a57ce | 51674ad0-4c9f-5b02-e054-00144ff88e88 |
| 68071-3278-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5fbf-f424-e053-dadaa90a57ce | 51674ad0-4c9f-5b02-e054-00144ff88e88 |