bupropion hydrochloride xl

Generic: bupropion hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride xl
Generic Name bupropion hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-923
Product ID 76420-923_2ef18e19-2e59-5756-e063-6394a90a1a03
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077715
Listing Expiration 2026-12-31
Marketing Start 2008-11-26

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 76420923
Hyphenated Format 76420-923

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 ANDA077715 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-05)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-30)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-60)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-90)
source: ndc

Packages (5)

Ingredients (1)

bupropion hydrochloride (150 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2ef18e19-2e59-5756-e063-6394a90a1a03", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993541"], "spl_set_id": ["d1d0872c-5b11-4e13-a401-b122348e0fa7"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-01)", "package_ndc": "76420-923-01", "marketing_start_date": "20250225"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-05)", "package_ndc": "76420-923-05", "marketing_start_date": "20250225"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-30)", "package_ndc": "76420-923-30", "marketing_start_date": "20250225"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-60)", "package_ndc": "76420-923-60", "marketing_start_date": "20250225"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76420-923-90)", "package_ndc": "76420-923-90", "marketing_start_date": "20250225"}], "brand_name": "Bupropion Hydrochloride XL", "product_id": "76420-923_2ef18e19-2e59-5756-e063-6394a90a1a03", "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": "76420-923", "generic_name": "Bupropion Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "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": "ANDA077715", "marketing_category": "ANDA", "marketing_start_date": "20081126", "listing_expiration_date": "20261231"}