paroxetine

Generic: paroxetine hydrochloride hemihydrate

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

Drug Facts

Product Profile

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

paroxetine hydrochloride hemihydrate 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-204
Product ID 71610-204_127e7f93-615c-45d1-91a6-98091c1e2d81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078902
Listing Expiration 2026-12-31
Marketing Start 2008-03-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610204
Hyphenated Format 71610-204

Supplemental Identifiers

RxCUI
1738483
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 hydrochloride hemihydrate (source: ndc)
Application Number ANDA078902 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-204-60)
source: ndc

Packages (1)

71610-204-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-204-60)

Ingredients (1)

paroxetine hydrochloride hemihydrate (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": "127e7f93-615c-45d1-91a6-98091c1e2d81", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483"], "spl_set_id": ["2eebd2b6-7c64-45ca-8eb5-5201137f610a"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-204-60)", "package_ndc": "71610-204-60", "marketing_start_date": "20181213"}], "brand_name": "Paroxetine", "product_id": "71610-204_127e7f93-615c-45d1-91a6-98091c1e2d81", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71610-204", "generic_name": "paroxetine hydrochloride hemihydrate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "10 mg/1"}], "application_number": "ANDA078902", "marketing_category": "ANDA", "marketing_start_date": "20080324", "listing_expiration_date": "20261231"}