paroxetine

Generic: paroxetine

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paroxetine
Generic Name paroxetine
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paroxetine hydrochloride 12.5 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-335
Product ID 69367-335_0a272d00-5b37-47b2-870a-0028ca799109
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213485
Listing Expiration 2026-12-31
Marketing Start 2021-07-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367335
Hyphenated Format 69367-335

Supplemental Identifiers

RxCUI
1738803 1738805 1738807
UPC
0369367337304
UNII
X2ELS050D8

Packaging Origin

Original Packager
true

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 (source: ndc)
Application Number ANDA213485 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-335-30)
source: ndc

Packages (1)

69367-335-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-335-30)

Ingredients (1)

paroxetine hydrochloride (12.5 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": "0a272d00-5b37-47b2-870a-0028ca799109", "openfda": {"upc": ["0369367337304"], "unii": ["X2ELS050D8"], "rxcui": ["1738803", "1738805", "1738807"], "spl_set_id": ["f39a2a7a-7a7e-4dd8-9704-54d9598504fb"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69367-335-30)", "package_ndc": "69367-335-30", "marketing_start_date": "20210726"}], "brand_name": "Paroxetine", "product_id": "69367-335_0a272d00-5b37-47b2-870a-0028ca799109", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "69367-335", "generic_name": "Paroxetine", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paroxetine", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA213485", "marketing_category": "ANDA", "marketing_start_date": "20210726", "listing_expiration_date": "20261231"}