bupropion hydrochloride

Generic: bupropion hydrochloride

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

Drug Facts

Product Profile

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

bupropion hydrochloride 300 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-812
Product ID 76420-812_2dffd9ed-8b4a-a56b-e063-6394a90ae043
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077285
Listing Expiration 2026-12-31
Marketing Start 2015-02-17

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 76420812
Hyphenated Format 76420-812

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 (source: ndc)
Generic Name bupropion hydrochloride (source: ndc)
Application Number ANDA077285 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-90)
source: ndc

Packages (5)

76420-812-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-01) 76420-812-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-05) 76420-812-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-30) 76420-812-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-60) 76420-812-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-90)

Ingredients (1)

bupropion hydrochloride (300 mg/1)

Linked Drug Pages (1)

Bupropion Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2dffd9ed-8b4a-a56b-e063-6394a90ae043", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993557"], "spl_set_id": ["637e89e5-8f6e-4392-8045-a778cb9ed138"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-01)", "package_ndc": "76420-812-01", "marketing_start_date": "20240507"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-05)", "package_ndc": "76420-812-05", "marketing_start_date": "20240507"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-30)", "package_ndc": "76420-812-30", "marketing_start_date": "20240507"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-60)", "package_ndc": "76420-812-60", "marketing_start_date": "20240507"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-812-90)", "package_ndc": "76420-812-90", "marketing_start_date": "20240507"}], "brand_name": "Bupropion Hydrochloride", "product_id": "76420-812_2dffd9ed-8b4a-a56b-e063-6394a90ae043", "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": "76420-812", "generic_name": "Bupropion Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA077285", "marketing_category": "ANDA", "marketing_start_date": "20150217", "listing_expiration_date": "20261231"}