paroxetine

Generic: paroxetine hydrochloride

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

paroxetine hydrochloride anhydrous 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 67544-492
Product ID 67544-492_1bb37fe5-45ba-4f89-b480-35fa1dedf247
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075356
Listing Expiration 2026-12-31
Marketing Start 2003-09-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67544492
Hyphenated Format 67544-492

Supplemental Identifiers

RxCUI
1738511
UNII
3I3T11UD2S

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 (source: ndc)
Application Number ANDA075356 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (67544-492-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (67544-492-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (67544-492-45)
source: ndc

Packages (3)

67544-492-15 15 TABLET, FILM COATED in 1 BOTTLE (67544-492-15) 67544-492-30 30 TABLET, FILM COATED in 1 BOTTLE (67544-492-30) 67544-492-45 45 TABLET, FILM COATED in 1 BOTTLE (67544-492-45)

Ingredients (1)

paroxetine hydrochloride anhydrous (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": "1bb37fe5-45ba-4f89-b480-35fa1dedf247", "openfda": {"unii": ["3I3T11UD2S"], "rxcui": ["1738511"], "spl_set_id": ["a7128be7-7023-40c4-aa64-29d52145ae31"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (67544-492-15)", "package_ndc": "67544-492-15", "marketing_start_date": "20180710"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67544-492-30)", "package_ndc": "67544-492-30", "marketing_start_date": "20180710"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (67544-492-45)", "package_ndc": "67544-492-45", "marketing_start_date": "20180710"}], "brand_name": "PAROXETINE", "product_id": "67544-492_1bb37fe5-45ba-4f89-b480-35fa1dedf247", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "67544-492", "generic_name": "paroxetine hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAROXETINE", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE ANHYDROUS", "strength": "40 mg/1"}], "application_number": "ANDA075356", "marketing_category": "ANDA", "marketing_start_date": "20030908", "listing_expiration_date": "20261231"}