paroxetine

Generic: paroxetine

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 20 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0339
Product ID 80425-0339_2a9bf7d3-46dd-0dfa-e063-6394a90a76a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077584
Listing Expiration 2026-12-31
Marketing Start 2023-05-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250339
Hyphenated Format 80425-0339

Supplemental Identifiers

RxCUI
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 (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 (80425-0339-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0339-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0339-3)
source: ndc

Packages (3)

80425-0339-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0339-1) 80425-0339-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0339-2) 80425-0339-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0339-3)

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": "2a9bf7d3-46dd-0dfa-e063-6394a90a76a4", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738495"], "spl_set_id": ["fc11a056-7db5-1966-e053-6394a90aa59c"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0339-1)", "package_ndc": "80425-0339-1", "marketing_start_date": "20230519"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0339-2)", "package_ndc": "80425-0339-2", "marketing_start_date": "20230519"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0339-3)", "package_ndc": "80425-0339-3", "marketing_start_date": "20230519"}], "brand_name": "Paroxetine", "product_id": "80425-0339_2a9bf7d3-46dd-0dfa-e063-6394a90a76a4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "80425-0339", "generic_name": "Paroxetine", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "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": "20230519", "listing_expiration_date": "20261231"}