paroxetine

Generic: paroxetine hydrochloride

Labeler: preferred pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride
Labeler preferred pharmaceuticals, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 20 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 68788-9074
Product ID 68788-9074_0264eeca-5671-466c-96ec-ab81e0c114d1
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 687889074
Hyphenated Format 68788-9074

Supplemental Identifiers

RxCUI
1738483 1738495
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 (source: ndc)
Application Number ANDA077584 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-6)
  • 120 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-9)
source: ndc

Packages (5)

68788-9074-1 100 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-1) 68788-9074-3 30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-3) 68788-9074-6 60 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-6) 68788-9074-8 120 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-8) 68788-9074-9 90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-9)

Ingredients (1)

paroxetine hydrochloride (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": "0264eeca-5671-466c-96ec-ab81e0c114d1", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495"], "spl_set_id": ["605c1d23-c97c-4ea4-92d0-fed351de9d2e"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-1)", "package_ndc": "68788-9074-1", "marketing_start_date": "20070413"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-3)", "package_ndc": "68788-9074-3", "marketing_start_date": "20070413"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-6)", "package_ndc": "68788-9074-6", "marketing_start_date": "20070413"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-8)", "package_ndc": "68788-9074-8", "marketing_start_date": "20070413"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (68788-9074-9)", "package_ndc": "68788-9074-9", "marketing_start_date": "20070413"}], "brand_name": "Paroxetine", "product_id": "68788-9074_0264eeca-5671-466c-96ec-ab81e0c114d1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68788-9074", "generic_name": "Paroxetine Hydrochloride", "labeler_name": "Preferred Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA077584", "marketing_category": "ANDA", "marketing_start_date": "20070413", "listing_expiration_date": "20261231"}