paroxetine

Generic: paroxetine hydrochloride hemihydrate

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride hemihydrate
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8829
Product ID 68788-8829_91c5a321-e174-4d86-9a84-e5e278d45aff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203854
Listing Expiration 2026-12-31
Marketing Start 2025-02-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888829
Hyphenated Format 68788-8829

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 ANDA203854 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8829-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8829-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8829-6)
  • 120 TABLET, FILM COATED in 1 BOTTLE (68788-8829-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8829-9)
source: ndc

Packages (5)

68788-8829-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8829-1) 68788-8829-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8829-3) 68788-8829-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8829-6) 68788-8829-8 120 TABLET, FILM COATED in 1 BOTTLE (68788-8829-8) 68788-8829-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8829-9)

Ingredients (1)

paroxetine hydrochloride (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": "91c5a321-e174-4d86-9a84-e5e278d45aff", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738483"], "spl_set_id": ["91c5a321-e174-4d86-9a84-e5e278d45aff"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8829-1)", "package_ndc": "68788-8829-1", "marketing_start_date": "20250213"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8829-3)", "package_ndc": "68788-8829-3", "marketing_start_date": "20250213"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8829-6)", "package_ndc": "68788-8829-6", "marketing_start_date": "20250213"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (68788-8829-8)", "package_ndc": "68788-8829-8", "marketing_start_date": "20250213"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8829-9)", "package_ndc": "68788-8829-9", "marketing_start_date": "20250213"}], "brand_name": "Paroxetine", "product_id": "68788-8829_91c5a321-e174-4d86-9a84-e5e278d45aff", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68788-8829", "generic_name": "paroxetine hydrochloride hemihydrate", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA203854", "marketing_category": "ANDA", "marketing_start_date": "20250213", "listing_expiration_date": "20261231"}