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 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-544
Product ID 43353-544_37d67ac2-1470-43aa-a06d-b24981539fd4
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 43353544
Hyphenated Format 43353-544

Supplemental Identifiers

RxCUI
1738495 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 hydrochloride hemihydrate (source: ndc)
Application Number ANDA078902 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-45)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-60)
source: ndc

Packages (4)

43353-544-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-15) 43353-544-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-30) 43353-544-45 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-45) 43353-544-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-60)

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": "37d67ac2-1470-43aa-a06d-b24981539fd4", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738495", "1738511"], "spl_set_id": ["ec9622ca-1f56-4216-9445-485791c4c0ed"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-15)", "package_ndc": "43353-544-15", "marketing_start_date": "20090921"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-30)", "package_ndc": "43353-544-30", "marketing_start_date": "20190201"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-45)", "package_ndc": "43353-544-45", "marketing_start_date": "20100112"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-60)", "package_ndc": "43353-544-60", "marketing_start_date": "20190318"}], "brand_name": "Paroxetine", "product_id": "43353-544_37d67ac2-1470-43aa-a06d-b24981539fd4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "43353-544", "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": "40 mg/1"}], "application_number": "ANDA078902", "marketing_category": "ANDA", "marketing_start_date": "20080324", "listing_expiration_date": "20261231"}