Paroxetine
- Product NDC
- 53002-2174
- 11-digit product format
- 530022174
- Labeler code
- 53002
- Product ID
- 53002-2174_009457d8-e42a-48d3-9add-5122b9a45895
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2174-3 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2174 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 1 package rows | 20210106_0699b158-bcc8-4075-baef-12b8386deea1.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 |
|---|
| 53002-2174-3 | 53002217403 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-2174-3) | 2019-01-01 | 0000-00-00 | No | No | Current |