paroxetine

Generic: paroxetine hydrochloride hemihydrate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride hemihydrate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 40 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-053
Product ID 55289-053_34663b6d-d8b7-08ea-e063-6294a90a6358
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078902
Listing Expiration 2026-12-31
Marketing Start 2008-03-24

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55289053
Hyphenated Format 55289-053

Supplemental Identifiers

RxCUI
1738511
UPC
0355289053903
UNII
X2ELS050D8

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name paroxetine (source: ndc)
Generic Name paroxetine hydrochloride hemihydrate (source: ndc)
Application Number ANDA078902 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-45)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-90)
source: ndc

Packages (2)

55289-053-45 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-45) 55289-053-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-90)

Ingredients (1)

paroxetine hydrochloride (40 mg/1)

Linked Drug Pages (1)

Paroxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34663b6d-d8b7-08ea-e063-6294a90a6358", "openfda": {"upc": ["0355289053903"], "unii": ["X2ELS050D8"], "rxcui": ["1738511"], "spl_set_id": ["619e10bb-6e5d-4ec3-a85a-6270965f5389"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-45)", "package_ndc": "55289-053-45", "marketing_start_date": "20110401"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-053-90)", "package_ndc": "55289-053-90", "marketing_start_date": "20110401"}], "brand_name": "Paroxetine", "product_id": "55289-053_34663b6d-d8b7-08ea-e063-6294a90a6358", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "55289-053", "generic_name": "paroxetine hydrochloride hemihydrate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA078902", "marketing_category": "ANDA", "marketing_start_date": "20080324", "listing_expiration_date": "20261231"}