bupropion hydrochloride

Generic: bupropion hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride
Generic Name bupropion hydrochloride
Labeler avpak
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-134
Product ID 50268-134_2f9c516e-9c18-af30-e063-6394a90a4a70
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090693
Listing Expiration 2026-12-31
Marketing Start 2025-03-05

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 50268134
Hyphenated Format 50268-134

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX (50268-134-13) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-134-11)
source: ndc

Packages (1)

50268-134-13 30 BLISTER PACK in 1 BOX (50268-134-13) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-134-11)

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": "2f9c516e-9c18-af30-e063-6394a90a4a70", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["2f9c5162-a6c5-e362-e063-6294a90a198d"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (50268-134-13)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-134-11)", "package_ndc": "50268-134-13", "marketing_start_date": "20250305"}], "brand_name": "Bupropion Hydrochloride", "product_id": "50268-134_2f9c516e-9c18-af30-e063-6394a90a4a70", "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": "50268-134", "generic_name": "Bupropion Hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA090693", "marketing_category": "ANDA", "marketing_start_date": "20250305", "listing_expiration_date": "20261231"}