bupropion hydrochloride (xl) (83301-0024)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (xl)

Generic Name bupropion hydrochloride

Labeler mullan pharmaceutical inc.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer

Mullan Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 83301-0024

Product ID 83301-0024_4990307c-8f79-4a7b-e063-6294a90a7b94

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208652

Listing Expiration 2027-12-31

Marketing Start 2024-06-17

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 833010024

Hyphenated Format 83301-0024

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 ANDA208652 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

150 mg/1

source: ndc

Packaging

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-1)
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-2)
500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-3)
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-4)

source: ndc

Packages (4)

83301-0024-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-1) 83301-0024-2 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-2) 83301-0024-3 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-3) 83301-0024-4 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-4)

Ingredients (1)

bupropion hydrochloride (150 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": "4990307c-8f79-4a7b-e063-6294a90a7b94", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["75b1e027-4c5d-46e5-98ee-033e67bd411c"], "manufacturer_name": ["Mullan Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-1)", "package_ndc": "83301-0024-1", "marketing_start_date": "20240617"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-2)", "package_ndc": "83301-0024-2", "marketing_start_date": "20240617"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-3)", "package_ndc": "83301-0024-3", "marketing_start_date": "20240617"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0024-4)", "package_ndc": "83301-0024-4", "marketing_start_date": "20240617"}], "brand_name": "Bupropion Hydrochloride (XL)", "product_id": "83301-0024_4990307c-8f79-4a7b-e063-6294a90a7b94", "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": "83301-0024", "generic_name": "Bupropion Hydrochloride", "labeler_name": "Mullan Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride (XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA208652", "marketing_category": "ANDA", "marketing_start_date": "20240617", "listing_expiration_date": "20271231"}