paroxetine

Generic: paroxetine

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 40 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-719
Product ID 76420-719_2e000f86-0592-a362-e063-6394a90a169d
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 76420719
Hyphenated Format 76420-719

Supplemental Identifiers

RxCUI
1738483 1738495 1738503 1738511
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
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-719-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76420-719-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (76420-719-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-719-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-719-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-719-90)
source: ndc

Packages (6)

76420-719-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-719-01) 76420-719-05 500 TABLET, FILM COATED in 1 BOTTLE (76420-719-05) 76420-719-10 1000 TABLET, FILM COATED in 1 BOTTLE (76420-719-10) 76420-719-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-719-30) 76420-719-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-719-60) 76420-719-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-719-90)

Ingredients (1)

paroxetine hydrochloride hemihydrate (40 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": "2e000f86-0592-a362-e063-6394a90a169d", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["4acd3e7a-4f19-4428-9452-48ce370cb3db"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-719-01)", "package_ndc": "76420-719-01", "marketing_start_date": "20240506"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76420-719-05)", "package_ndc": "76420-719-05", "marketing_start_date": "20240506"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (76420-719-10)", "package_ndc": "76420-719-10", "marketing_start_date": "20240506"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-719-30)", "package_ndc": "76420-719-30", "marketing_start_date": "20240506"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-719-60)", "package_ndc": "76420-719-60", "marketing_start_date": "20240506"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-719-90)", "package_ndc": "76420-719-90", "marketing_start_date": "20240506"}], "brand_name": "Paroxetine", "product_id": "76420-719_2e000f86-0592-a362-e063-6394a90a169d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "76420-719", "generic_name": "Paroxetine", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA077584", "marketing_category": "ANDA", "marketing_start_date": "20070413", "listing_expiration_date": "20261231"}