Paroxetine
- Product NDC
- 55289-037
- 11-digit product format
- 552890037
- Labeler code
- 55289
- Product ID
- 55289-037_3465ea08-4468-da4e-e063-6294a90a11b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078902
- Marketing category
- ANDA
- Marketing start
- 2008-03-24
- Substance
- PAROXETINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Paroxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
| Rxcui | 1738483 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-037-45 | Paroxetine | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 24 |
| 55289-037-90 | Paroxetine | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 24 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-037 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 24 | Current NDC, Legacy NDC, 2 package rows | 20250507_ff7c7e20-c9ee-4693-beaa-7ac532d5c4b7.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 |
|---|
| 55289-037-45 | 55289003745 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-037-45) | 2011-08-01 | 0000-00-00 | No | No | Current |
| 55289-037-90 | 55289003790 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-037-90) | 2011-08-01 | 0000-00-00 | No | No | Current |