Paroxetine
- Product NDC
- 50090-0848
- 11-digit product format
- 500900848
- Labeler code
- 50090
- Product ID
- 50090-0848_67dd70df-0747-4d04-ae19-6fda76e9a147
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078406
- Marketing category
- ANDA
- Marketing start
- 2009-12-03
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-0848-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-08aa-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP Rx only |
| 50090-0848-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-08aa-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP Rx only |
| 50090-0848-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-08aa-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP Rx only |
| 50090-0848-0 | 2021-06-16 | C162847 | 48780-1 | 9d75b9d0-08aa-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP Rx only |
| 50090-0848-1 | 2021-06-16 | C162847 | 48780-1 | 9d75b9d0-08aa-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP Rx only |
| 50090-0848-2 | 2021-06-16 | C162847 | 48780-1 | 9d75b9d0-08aa-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP Rx only |
| 50090-0848-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-08aa-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP Rx only |
| 50090-0848-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-08aa-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP Rx only |
| 50090-0848-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-08aa-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-0848-0 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
| 50090-0848-1 | Paroxetine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 12 |
| 50090-0848-2 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-0848 | PAROXETINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 12 | Legacy NDC, 3 package rows | 20210616_ec4e1e42-713c-41ea-b62d-2f46b8b5be05.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-0848-0 | 50090084800 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-0848-0) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0848-1 | 50090084801 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-0848-1) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0848-2 | 50090084802 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-0848-2) | 2014-11-28 | 0000-00-00 | No | No | Current |