Paroxetine
- Product NDC
- 55289-053
- 11-digit product format
- 552890053
- Labeler code
- 55289
- Product ID
- 55289-053_34663b6d-d8b7-08ea-e063-6294a90a6358
- 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
- 40 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PAROXETINE HYDROCHLORIDE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X2ELS050D8 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-053-45 | Paroxetine | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 22 |
| 55289-053-90 | Paroxetine | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | ACTIVE INGREDIENT | X2ELS050D8 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| PAROXETINE | ACTIVE MOIETY | 41VRH5220H | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-053 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 22 | Current NDC, Legacy NDC, 2 package rows | 20250507_619e10bb-6e5d-4ec3-a85a-6270965f5389.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 |
|---|
| 55289-053-45 | 55289005345 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-45) | 2011-04-01 | 0000-00-00 | No | No | Current |
| 55289-053-90 | 55289005390 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-90) | 2011-04-01 | 0000-00-00 | No | No | Current |