paroxetine

Generic: paroxetine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 10 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-044
Product ID 68084-044_3f163cc0-999c-9fdd-e063-6394a90ac15e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077584
Listing Expiration 2026-12-31
Marketing Start 2005-03-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084044
Hyphenated Format 68084-044

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
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-044-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-044-11)
source: ndc

Packages (1)

68084-044-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-044-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-044-11)

Ingredients (1)

paroxetine hydrochloride (10 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": "3f163cc0-999c-9fdd-e063-6394a90ac15e", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["b5a8f864-a53d-48d9-aca6-6b64017fb168"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-044-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-044-11)", "package_ndc": "68084-044-01", "marketing_start_date": "20050315"}], "brand_name": "Paroxetine", "product_id": "68084-044_3f163cc0-999c-9fdd-e063-6394a90ac15e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68084-044", "generic_name": "Paroxetine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077584", "marketing_category": "ANDA", "marketing_start_date": "20050315", "listing_expiration_date": "20261231"}