paroxetine hydrochloride

Generic: paroxetine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine hydrochloride
Generic Name paroxetine hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paroxetine hydrochloride hemihydrate 25 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8527
Product ID 63629-8527_d72b03fa-f81e-4eab-95aa-00c6c48ebf37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204744
Listing Expiration 2026-12-31
Marketing Start 2014-10-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298527
Hyphenated Format 63629-8527

Supplemental Identifiers

RxCUI
1738805
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 hydrochloride (source: ndc)
Generic Name paroxetine hydrochloride (source: ndc)
Application Number ANDA204744 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-8527-1)
source: ndc

Packages (1)

63629-8527-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-8527-1)

Ingredients (1)

paroxetine hydrochloride hemihydrate (25 mg/1)

Linked Drug Pages (1)

Paroxetine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d72b03fa-f81e-4eab-95aa-00c6c48ebf37", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738805"], "spl_set_id": ["5e47c4fb-6070-4cb4-acaa-c6e90199b55c"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-8527-1)", "package_ndc": "63629-8527-1", "marketing_start_date": "20141031"}], "brand_name": "Paroxetine Hydrochloride", "product_id": "63629-8527_d72b03fa-f81e-4eab-95aa-00c6c48ebf37", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "63629-8527", "generic_name": "Paroxetine Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine Hydrochloride", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "25 mg/1"}], "application_number": "ANDA204744", "marketing_category": "ANDA", "marketing_start_date": "20141031", "listing_expiration_date": "20261231"}