paroxetine

Generic: paroxetine hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride anhydrous 20 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-098
Product ID 65841-098_ef5c1ef5-2884-4395-a65a-92591c986150
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 65841098
Hyphenated Format 65841-098

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
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 ANDA077584 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65841-098-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65841-098-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65841-098-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65841-098-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65841-098-16)
source: ndc

Packages (5)

65841-098-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-098-01) 65841-098-05 500 TABLET, FILM COATED in 1 BOTTLE (65841-098-05) 65841-098-06 30 TABLET, FILM COATED in 1 BOTTLE (65841-098-06) 65841-098-10 1000 TABLET, FILM COATED in 1 BOTTLE (65841-098-10) 65841-098-16 90 TABLET, FILM COATED in 1 BOTTLE (65841-098-16)

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": "ef5c1ef5-2884-4395-a65a-92591c986150", "openfda": {"unii": ["3I3T11UD2S"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["6d5fcdb2-4d84-4b20-87e3-58a43e567500"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65841-098-01)", "package_ndc": "65841-098-01", "marketing_start_date": "20070413"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65841-098-05)", "package_ndc": "65841-098-05", "marketing_start_date": "20070413"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65841-098-06)", "package_ndc": "65841-098-06", "marketing_start_date": "20070413"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65841-098-10)", "package_ndc": "65841-098-10", "marketing_start_date": "20070413"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65841-098-16)", "package_ndc": "65841-098-16", "marketing_start_date": "20070413"}], "brand_name": "Paroxetine", "product_id": "65841-098_ef5c1ef5-2884-4395-a65a-92591c986150", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "65841-098", "generic_name": "Paroxetine Hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE ANHYDROUS", "strength": "20 mg/1"}], "application_number": "ANDA077584", "marketing_category": "ANDA", "marketing_start_date": "20070413", "listing_expiration_date": "20261231"}