paroxetine hydrochloride

Generic: paroxetine hydrochloride

Labeler: oxford pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paroxetine hydrochloride 30 mg/1

Manufacturer
Oxford Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69584-673
Product ID 69584-673_2ac7f06f-af78-4705-a209-d9041b2de825
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076968
Listing Expiration 2026-12-31
Marketing Start 2022-11-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69584673
Hyphenated Format 69584-673

Supplemental Identifiers

RxCUI
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 paroxetine hydrochloride (source: ndc)
Generic Name paroxetine hydrochloride (source: ndc)
Application Number ANDA076968 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (69584-673-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (69584-673-09)
  • 100 TABLET, FILM COATED in 1 BOTTLE (69584-673-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (69584-673-50)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (69584-673-90)
source: ndc

Packages (5)

69584-673-03 30 TABLET, FILM COATED in 1 BOTTLE (69584-673-03) 69584-673-09 90 TABLET, FILM COATED in 1 BOTTLE (69584-673-09) 69584-673-10 100 TABLET, FILM COATED in 1 BOTTLE (69584-673-10) 69584-673-50 500 TABLET, FILM COATED in 1 BOTTLE (69584-673-50) 69584-673-90 1000 TABLET, FILM COATED in 1 BOTTLE (69584-673-90)

Ingredients (1)

paroxetine hydrochloride (30 mg/1)

Linked Drug Pages (1)

paroxetine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2ac7f06f-af78-4705-a209-d9041b2de825", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["25182b68-8f7a-48e8-9788-6818b0984b29"], "manufacturer_name": ["Oxford Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69584-673-03)", "package_ndc": "69584-673-03", "marketing_start_date": "20221114"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (69584-673-09)", "package_ndc": "69584-673-09", "marketing_start_date": "20221114"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69584-673-10)", "package_ndc": "69584-673-10", "marketing_start_date": "20221114"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69584-673-50)", "package_ndc": "69584-673-50", "marketing_start_date": "20221114"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69584-673-90)", "package_ndc": "69584-673-90", "marketing_start_date": "20221114"}], "brand_name": "paroxetine hydrochloride", "product_id": "69584-673_2ac7f06f-af78-4705-a209-d9041b2de825", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "69584-673", "generic_name": "paroxetine hydrochloride", "labeler_name": "Oxford Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "paroxetine hydrochloride", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA076968", "marketing_category": "ANDA", "marketing_start_date": "20221114", "listing_expiration_date": "20261231"}