bupropion hydrochloride (xl) (80425-0539)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (xl)

Generic Name bupropion hydrochloride

Labeler advanced rx of tennessee, llc

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer

Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0539

Product ID 80425-0539_3d826804-6428-aae1-e063-6394a90a6593

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207479

Listing Expiration 2026-12-31

Marketing Start 2025-08-29

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 804250539

Hyphenated Format 80425-0539

Supplemental Identifiers

RxCUI

993557

UNII

ZG7E5POY8O

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 ANDA207479 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-1)
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-2)
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-3)

source: ndc

Packages (3)

80425-0539-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-1) 80425-0539-2 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-2) 80425-0539-3 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-3)

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": "3d826804-6428-aae1-e063-6394a90a6593", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993557"], "spl_set_id": ["3d826804-6427-aae1-e063-6394a90a6593"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-1)", "package_ndc": "80425-0539-1", "marketing_start_date": "20250829"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-2)", "package_ndc": "80425-0539-2", "marketing_start_date": "20250829"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-3)", "package_ndc": "80425-0539-3", "marketing_start_date": "20250829"}], "brand_name": "Bupropion Hydrochloride (XL)", "product_id": "80425-0539_3d826804-6428-aae1-e063-6394a90a6593", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "80425-0539", "generic_name": "bupropion hydrochloride", "labeler_name": "Advanced Rx of Tennessee, 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": "ANDA207479", "marketing_category": "ANDA", "marketing_start_date": "20250829", "listing_expiration_date": "20261231"}