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 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 67544-317
Product ID 67544-317_4569b4c4-1f9a-4dcb-96f7-296bb6ef34e7
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 67544317
Hyphenated Format 67544-317

Supplemental Identifiers

RxCUI
1738495
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
  • 20 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (67544-317-15)
  • 45 TABLET, FILM COATED in 1 BOTTLE (67544-317-45)
source: ndc

Packages (2)

67544-317-15 15 TABLET, FILM COATED in 1 BOTTLE (67544-317-15) 67544-317-45 45 TABLET, FILM COATED in 1 BOTTLE (67544-317-45)

Ingredients (1)

paroxetine hydrochloride anhydrous (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": "4569b4c4-1f9a-4dcb-96f7-296bb6ef34e7", "openfda": {"unii": ["3I3T11UD2S"], "rxcui": ["1738495"], "spl_set_id": ["1801246b-02c3-430f-932a-b18cb0d13d1d"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (67544-317-15)", "package_ndc": "67544-317-15", "marketing_start_date": "20180430"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (67544-317-45)", "package_ndc": "67544-317-45", "marketing_start_date": "20181012"}], "brand_name": "PAROXETINE", "product_id": "67544-317_4569b4c4-1f9a-4dcb-96f7-296bb6ef34e7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "67544-317", "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": "20 mg/1"}], "application_number": "ANDA075356", "marketing_category": "ANDA", "marketing_start_date": "20030908", "listing_expiration_date": "20261231"}