paroxetine hydrochloride

Generic: paroxetine hydrochloride

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine hydrochloride
Generic Name paroxetine hydrochloride
Labeler apotex corp
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 25 mg/1

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-1317
Product ID 60505-1317_f641c7b3-f7d2-9446-e589-074ac368853a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020936
Listing Expiration 2026-12-31
Marketing Start 2019-08-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605051317
Hyphenated Format 60505-1317

Supplemental Identifiers

RxCUI
1738803 1738805 1738807
UPC
0360505367436 0360505367535 0360505367337
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 NDA020936 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1317-3)
source: ndc

Packages (1)

60505-1317-3 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1317-3)

Ingredients (1)

paroxetine hydrochloride hemihydrate (25 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": "f641c7b3-f7d2-9446-e589-074ac368853a", "openfda": {"upc": ["0360505367436", "0360505367535", "0360505367337"], "unii": ["X2ELS050D8"], "rxcui": ["1738803", "1738805", "1738807"], "spl_set_id": ["087ff0d3-1761-47ea-a8c1-7c4cb679af97"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-1317-3)", "package_ndc": "60505-1317-3", "marketing_start_date": "20190809"}], "brand_name": "PAROXETINE HYDROCHLORIDE", "product_id": "60505-1317_f641c7b3-f7d2-9446-e589-074ac368853a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "60505-1317", "generic_name": "paroxetine hydrochloride", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAROXETINE HYDROCHLORIDE", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "25 mg/1"}], "application_number": "NDA020936", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190809", "listing_expiration_date": "20261231"}