paroxetine

Generic: paroxetine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-713
Product ID 43353-713_85b2c456-e237-42da-aa5c-415dc3326154
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078406
Listing Expiration 2026-12-31
Marketing Start 2009-12-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353713
Hyphenated Format 43353-713

Supplemental Identifiers

RxCUI
1738495
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
  • 20 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (43353-713-15)
  • 45 TABLET, FILM COATED in 1 BOTTLE (43353-713-45)
source: ndc

Packages (2)

43353-713-15 15 TABLET, FILM COATED in 1 BOTTLE (43353-713-15) 43353-713-45 45 TABLET, FILM COATED in 1 BOTTLE (43353-713-45)

Ingredients (1)

paroxetine hydrochloride hemihydrate (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": "85b2c456-e237-42da-aa5c-415dc3326154", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738495"], "spl_set_id": ["662223ec-3b9b-4a85-9680-789522363a7b"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (43353-713-15)", "package_ndc": "43353-713-15", "marketing_start_date": "20110322"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (43353-713-45)", "package_ndc": "43353-713-45", "marketing_start_date": "20180502"}], "brand_name": "Paroxetine", "product_id": "43353-713_85b2c456-e237-42da-aa5c-415dc3326154", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43353-713", "generic_name": "Paroxetine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA078406", "marketing_category": "ANDA", "marketing_start_date": "20091203", "listing_expiration_date": "20261231"}