paroxetine

Generic: paroxetine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler avpak
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 40 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-643
Product ID 50268-643_47442798-ab7c-7d4c-e063-6394a90a1082
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078406
Listing Expiration 2026-12-31
Marketing Start 2016-03-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268643
Hyphenated Format 50268-643

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 ANDA078406 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-643-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-643-11)
source: ndc

Packages (1)

50268-643-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-643-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-643-11)

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": "47442798-ab7c-7d4c-e063-6394a90a1082", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483", "1738495", "1738503", "1738511"], "spl_set_id": ["d9a5e0aa-e638-5d6e-75c2-20cb78fc4f43"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-643-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-643-11)", "package_ndc": "50268-643-15", "marketing_start_date": "20160311"}], "brand_name": "Paroxetine", "product_id": "50268-643_47442798-ab7c-7d4c-e063-6394a90a1082", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50268-643", "generic_name": "Paroxetine", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA078406", "marketing_category": "ANDA", "marketing_start_date": "20160311", "listing_expiration_date": "20261231"}