bupropion hydrochloride xl

Generic: bupropion hydrochloride

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride xl
Generic Name bupropion hydrochloride
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-052
Product ID 82009-052_cd0aee48-be2a-4cc8-964d-fcc1c991c185
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090693
Listing Expiration 2026-12-31
Marketing Start 2023-07-07

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 82009052
Hyphenated Format 82009-052

Supplemental Identifiers

RxCUI
993541 993557
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 ANDA090693 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (82009-052-05)
source: ndc

Packages (1)

82009-052-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (82009-052-05)

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": "cd0aee48-be2a-4cc8-964d-fcc1c991c185", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["56df4e22-81ca-48a4-a8e2-038448417355"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (82009-052-05)", "package_ndc": "82009-052-05", "marketing_start_date": "20230707"}], "brand_name": "Bupropion Hydrochloride XL", "product_id": "82009-052_cd0aee48-be2a-4cc8-964d-fcc1c991c185", "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": "82009-052", "generic_name": "Bupropion Hydrochloride", "labeler_name": "Quallent Pharmaceuticals Health 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": "ANDA090693", "marketing_category": "ANDA", "marketing_start_date": "20230707", "listing_expiration_date": "20261231"}