Paroxetine
- Product NDC
- 53002-1174
- 11-digit product format
- 530021174
- Labeler code
- 53002
- Product ID
- 53002-1174_afb20851-3a6b-4e4a-bcdf-14630db35cf2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2007-04-13
- 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
- 2021-12-31
- 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 |
|---|
| 53002-1174-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-4339-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP |
| 53002-1174-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-4339-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP |
| 53002-1174-6 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-4339-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP |
| 53002-1174-1 | 2021-01-05 | C162847 | 48780-1 | 9d75b9d0-4339-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP |
| 53002-1174-3 | 2021-01-05 | C162847 | 48780-1 | 9d75b9d0-4339-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP |
| 53002-1174-6 | 2021-01-05 | C162847 | 48780-1 | 9d75b9d0-4339-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP |
| 53002-1174-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4339-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP |
| 53002-1174-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4339-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP |
| 53002-1174-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4339-f424-e053-dadaa90a57ce | Paroxetine Tablets, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1174-1 | Paroxetine | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 3 |
| 53002-1174-3 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 53002-1174-6 | Paroxetine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1174 | PAROXETINE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 package rows | 20210105_ac66f232-b392-463b-a90c-5b3b5e13b141.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 |
|---|
| 53002-1174-1 | 53002117401 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-1174-1) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1174-3 | 53002117403 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-1174-3) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1174-6 | 53002117406 | 60 TABLET, FILM COATED in 1 BOTTLE (53002-1174-6) | 2017-09-01 | 0000-00-00 | No | No | Current |