bupropion hydrochloride (xl) (83301-0025)

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 300 mg/1

Manufacturer

Mullan Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 83301-0025

Product ID 83301-0025_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 833010025

Hyphenated Format 83301-0025

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

300 mg/1

source: ndc

Packaging

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-1)
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-2)
500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-3)
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-4)

source: ndc

Packages (4)

83301-0025-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-1) 83301-0025-2 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-2) 83301-0025-3 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-3) 83301-0025-4 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-4)

Ingredients (1)

bupropion hydrochloride (300 mg/1)

Linked Drug Pages (1)

Bupropion Hydrochloride (XL) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

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