paroxetine

Generic: paroxetine hydrochloride hemihydrate

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

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine hydrochloride hemihydrate
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 63629-9499
Product ID 63629-9499_0c7051c2-7bef-402b-808d-1095f5eb52bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209293
Marketing Start 2018-09-14
Marketing End 2026-07-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636299499
Hyphenated Format 63629-9499

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 (source: ndc)
Generic Name paroxetine hydrochloride hemihydrate (source: ndc)
Application Number ANDA209293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9499-1)
source: ndc

Packages (1)

63629-9499-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9499-1)

Ingredients (1)

paroxetine hydrochloride hemihydrate (25 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": "0c7051c2-7bef-402b-808d-1095f5eb52bd", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738805"], "spl_set_id": ["51189cf4-4122-48d4-b47f-4f98a8dfb8e0"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9499-1)", "package_ndc": "63629-9499-1", "marketing_end_date": "20260731", "marketing_start_date": "20180914"}], "brand_name": "PAROXETINE", "product_id": "63629-9499_0c7051c2-7bef-402b-808d-1095f5eb52bd", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "63629-9499", "generic_name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAROXETINE", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "25 mg/1"}], "application_number": "ANDA209293", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "20180914"}