bupropion hydrochloride xl (69367-289)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride xl

Generic Name bupropion hydrochloride

Labeler westminster pharmaceuticals, llc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer

Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-289

Product ID 69367-289_19bc8511-a58b-da1c-e063-6394a90a5111

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207224

Listing Expiration 2026-12-31

Marketing Start 2017-10-01

Pharmacologic Class

Classes

aminoketone [epc] dopamine uptake inhibitors [moa] increased dopamine activity [pe] increased norepinephrine activity [pe] norepinephrine uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367289

Hyphenated Format 69367-289

Supplemental Identifiers

RxCUI

993541 993557

UPC

0369367289092 0369367288095

UNII

ZG7E5POY8O

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 bupropion hydrochloride xl (source: ndc)

Generic Name bupropion hydrochloride (source: ndc)

Application Number ANDA207224 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-289-05)
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-289-09)

source: ndc

Packages (2)

69367-289-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-289-05) 69367-289-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-289-09)

Ingredients (1)

bupropion hydrochloride (300 mg/1)

Linked Drug Pages (1)

Bupropion Hydrochloride XL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "19bc8511-a58b-da1c-e063-6394a90a5111", "openfda": {"upc": ["0369367289092", "0369367288095"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["c280efb9-b284-6a69-e053-2995a90a3035"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-289-05)", "package_ndc": "69367-289-05", "marketing_start_date": "20171001"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-289-09)", "package_ndc": "69367-289-09", "marketing_start_date": "20171001"}], "brand_name": "Bupropion Hydrochloride XL", "product_id": "69367-289_19bc8511-a58b-da1c-e063-6394a90a5111", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "69367-289", "generic_name": "Bupropion Hydrochloride", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "XL", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA207224", "marketing_category": "ANDA", "marketing_start_date": "20171001", "listing_expiration_date": "20261231"}