paroxetine

Generic: paroxetine

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

Drug Facts

Product Profile

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

paroxetine hydrochloride hemihydrate 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-972
Product ID 55289-972_419e8187-78f3-42a9-e063-6294a90a6680
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077584
Listing Expiration 2026-12-31
Marketing Start 2007-04-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55289972
Hyphenated Format 55289-972

Supplemental Identifiers

RxCUI
1738495
UPC
0355289972907
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 (source: ndc)
Application Number ANDA077584 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-90)
source: ndc

Packages (3)

55289-972-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-30) 55289-972-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-60) 55289-972-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-90)

Ingredients (1)

paroxetine hydrochloride hemihydrate (20 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": "419e8187-78f3-42a9-e063-6294a90a6680", "openfda": {"upc": ["0355289972907"], "unii": ["X2ELS050D8"], "rxcui": ["1738495"], "spl_set_id": ["c0acc97d-3d8d-4a7f-8acd-99050b0af2f1"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-30)", "package_ndc": "55289-972-30", "marketing_start_date": "20160210"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-60)", "package_ndc": "55289-972-60", "marketing_start_date": "20160210"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-972-90)", "package_ndc": "55289-972-90", "marketing_start_date": "20160210"}], "brand_name": "Paroxetine", "product_id": "55289-972_419e8187-78f3-42a9-e063-6294a90a6680", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "55289-972", "generic_name": "Paroxetine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA077584", "marketing_category": "ANDA", "marketing_start_date": "20070413", "listing_expiration_date": "20261231"}