PAROXETINE
- Product NDC
- 49999-632
- 11-digit product format
- 499990632
- Labeler code
- 49999
- Product ID
- 49999-632_310d646b-aced-4527-895d-8aa619802ef3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2011-11-08
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Active strength
- 20 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49999-632-00 | 2025-01-13 | C162847 | 48780-1 | 1030e365-0f6d-111a-e063-dadaa90a10e2 | c702df3b-584f-4a8e-8554-aa611e18ac4f |
| 49999-632-30 | 2025-01-13 | C162847 | 48780-1 | 1030e365-0f6d-111a-e063-dadaa90a10e2 | c702df3b-584f-4a8e-8554-aa611e18ac4f |
| 49999-632-60 | 2025-01-13 | C162847 | 48780-1 | 1030e365-0f6d-111a-e063-dadaa90a10e2 | c702df3b-584f-4a8e-8554-aa611e18ac4f |
| 49999-632-00 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0f6d-111a-e063-dadaa90a10e2 | c702df3b-584f-4a8e-8554-aa611e18ac4f |
| 49999-632-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0f6d-111a-e063-dadaa90a10e2 | c702df3b-584f-4a8e-8554-aa611e18ac4f |
| 49999-632-60 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0f6d-111a-e063-dadaa90a10e2 | c702df3b-584f-4a8e-8554-aa611e18ac4f |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49999-632-00 | EA - Each | 49999-632 | 28f29153-ce55-40fa-8566-f8fd5a3cc67c | 1 | 2012-07-24 |
| 49999-632-30 | EA - Each | 49999-632 | b682df85-30b1-4fd3-8a0d-5ed924b26c1b | 1 | 2012-07-24 |
| 49999-632-60 | EA - Each | 49999-632 | 7ca1661a-8a92-4e10-94f7-46c231064334 | 1 | 2012-07-24 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49999-632-30 | 49999063230 | 30 TABLET, FILM COATED in 1 BOTTLE (49999-632-30) | 2011-11-08 | 0000-00-00 | No | No | Current |