paxil

Generic: paroxetine hydrochloride

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name paxil
Generic Name paroxetine hydrochloride
Labeler apotex corp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 40 mg/1

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-4520
Product ID 60505-4520_62b4ffe1-48e2-6dd5-d7ca-28e8efe36686
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020031
Listing Expiration 2026-12-31
Marketing Start 2019-03-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054520
Hyphenated Format 60505-4520

Supplemental Identifiers

RxCUI
207349 207350 211699 211700 1738483 1738495 1738503 1738511
UNII
X2ELS050D8

Packaging Origin

Original Packager
true

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 paxil (source: ndc)
Generic Name paroxetine hydrochloride (source: ndc)
Application Number NDA020031 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-4520-3)
source: ndc

Packages (1)

60505-4520-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-4520-3)

Ingredients (1)

paroxetine hydrochloride (40 mg/1)

Linked Drug Pages (1)

PAXIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "62b4ffe1-48e2-6dd5-d7ca-28e8efe36686", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["207349", "207350", "211699", "211700", "1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["ef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-4520-3)", "package_ndc": "60505-4520-3", "marketing_start_date": "20190311"}], "brand_name": "PAXIL", "product_id": "60505-4520_62b4ffe1-48e2-6dd5-d7ca-28e8efe36686", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "60505-4520", "generic_name": "paroxetine hydrochloride", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAXIL", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "NDA020031", "marketing_category": "NDA", "marketing_start_date": "20190311", "listing_expiration_date": "20261231"}