bupropion hydrochloride (xl)

Generic: bupropion hydrochloride

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (xl)
Generic Name bupropion hydrochloride
Labeler quality care products, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-082
Product ID 83008-082_2f1417b0-2b35-4e9c-a9c4-e17d3d51d8e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207479
Marketing Start 2024-08-28
Marketing End 2026-12-31

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 83008082
Hyphenated Format 83008-082

Supplemental Identifiers

RxCUI
993541
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
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83008-082-30)
source: ndc

Packages (1)

83008-082-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83008-082-30)

Ingredients (1)

bupropion hydrochloride (150 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": "2f1417b0-2b35-4e9c-a9c4-e17d3d51d8e7", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993541"], "spl_set_id": ["57a9f4d3-0c41-4978-b81e-cf3059bc8c42"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83008-082-30)", "package_ndc": "83008-082-30", "marketing_end_date": "20261231", "marketing_start_date": "20240828"}], "brand_name": "Bupropion Hydrochloride (XL)", "product_id": "83008-082_2f1417b0-2b35-4e9c-a9c4-e17d3d51d8e7", "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": "83008-082", "generic_name": "bupropion hydrochloride", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "(XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA207479", "marketing_category": "ANDA", "marketing_end_date": "20261231", "marketing_start_date": "20240828"}