bupropion hydrochloride

Generic: bupropion hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride
Generic Name bupropion hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 100 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8601
Product ID 0615-8601_82d92152-92be-419f-a7a5-7b36b318ea1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216800
Listing Expiration 2026-12-31
Marketing Start 2023-05-31

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 06158601
Hyphenated Format 0615-8601

Supplemental Identifiers

RxCUI
993503 993518
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 ANDA216800 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8601-39)
source: ndc

Packages (1)

0615-8601-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8601-39)

Ingredients (1)

bupropion hydrochloride (100 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": "82d92152-92be-419f-a7a5-7b36b318ea1c", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993503", "993518"], "spl_set_id": ["1bd2ed35-35c5-464f-bf51-9dd4b42ee59a"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8601-39)", "package_ndc": "0615-8601-39", "marketing_start_date": "20251031"}], "brand_name": "Bupropion hydrochloride", "product_id": "0615-8601_82d92152-92be-419f-a7a5-7b36b318ea1c", "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": "0615-8601", "generic_name": "Bupropion hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA216800", "marketing_category": "ANDA", "marketing_start_date": "20230531", "listing_expiration_date": "20261231"}