paroxetine

Generic: paroxetine hydrochloride

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paroxetine hydrochloride anhydrous 20 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0083
Product ID 60505-0083_9cde2ef4-fd50-ed21-0628-cb6cd8a6153f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075356
Listing Expiration 2026-12-31
Marketing Start 2003-09-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050083
Hyphenated Format 60505-0083

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
UPC
0360505010110 0360505008414 0360505009718 0360505008315
UNII
3I3T11UD2S

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 paroxetine (source: ndc)
Generic Name paroxetine hydrochloride (source: ndc)
Application Number ANDA075356 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-0083-1)
  • 100 TABLET, FILM COATED in 1 BOTTLE (60505-0083-2)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (60505-0083-4)
source: ndc

Packages (3)

60505-0083-1 30 TABLET, FILM COATED in 1 BOTTLE (60505-0083-1) 60505-0083-2 100 TABLET, FILM COATED in 1 BOTTLE (60505-0083-2) 60505-0083-4 1000 TABLET, FILM COATED in 1 BOTTLE (60505-0083-4)

Ingredients (1)

paroxetine hydrochloride anhydrous (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": "9cde2ef4-fd50-ed21-0628-cb6cd8a6153f", "openfda": {"upc": ["0360505010110", "0360505008414", "0360505009718", "0360505008315"], "unii": ["3I3T11UD2S"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["08320ea3-8f93-6f04-5d1c-f69af3eb5a81"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-0083-1)", "package_ndc": "60505-0083-1", "marketing_start_date": "20030908"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (60505-0083-2)", "package_ndc": "60505-0083-2", "marketing_start_date": "20030908"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (60505-0083-4)", "package_ndc": "60505-0083-4", "marketing_start_date": "20030908"}], "brand_name": "PAROXETINE", "product_id": "60505-0083_9cde2ef4-fd50-ed21-0628-cb6cd8a6153f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "60505-0083", "generic_name": "paroxetine hydrochloride", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAROXETINE", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE ANHYDROUS", "strength": "20 mg/1"}], "application_number": "ANDA075356", "marketing_category": "ANDA", "marketing_start_date": "20030908", "listing_expiration_date": "20261231"}