bupropion hydrochloride xl

Generic: bupropion hydrochloride

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride xl
Generic Name bupropion hydrochloride
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0468
Product ID 80425-0468_2aabf642-2904-a735-e063-6394a90a83b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207224
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

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 804250468
Hyphenated Format 80425-0468

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 ANDA207224 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0468-1)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0468-2)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0468-3)
source: ndc

Packages (3)

80425-0468-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0468-1) 80425-0468-2 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0468-2) 80425-0468-3 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0468-3)

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": "2aabf642-2904-a735-e063-6394a90a83b5", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993557"], "spl_set_id": ["2aabf040-16a6-b772-e063-6294a90afd70"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0468-1)", "package_ndc": "80425-0468-1", "marketing_start_date": "20250101"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0468-2)", "package_ndc": "80425-0468-2", "marketing_start_date": "20250101"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0468-3)", "package_ndc": "80425-0468-3", "marketing_start_date": "20250101"}], "brand_name": "Bupropion Hydrochloride XL", "product_id": "80425-0468_2aabf642-2904-a735-e063-6394a90a83b5", "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": "80425-0468", "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": "ANDA207224", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}