bupropion hydrochloride (xl) (82804-013)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (xl)

Generic Name bupropion hydrochloride

Labeler proficient rx lp

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer

Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-013

Product ID 82804-013_80f4a4ef-8190-458d-af2e-5daaf32abc01

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA206556

Listing Expiration 2026-12-31

Marketing Start 2016-08-29

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 82804013

Hyphenated Format 82804-013

Supplemental Identifiers

RxCUI

993557

UPC

0382804013302

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 (xl) (source: ndc)

Generic Name bupropion hydrochloride (source: ndc)

Application Number ANDA206556 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-30)
60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-60)
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-90)

source: ndc

Packages (3)

82804-013-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-30) 82804-013-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-60) 82804-013-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-90)

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

{"route": ["ORAL"], "spl_id": "80f4a4ef-8190-458d-af2e-5daaf32abc01", "openfda": {"upc": ["0382804013302"], "unii": ["ZG7E5POY8O"], "rxcui": ["993557"], "spl_set_id": ["80f4a4ef-8190-458d-af2e-5daaf32abc01"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-30)", "package_ndc": "82804-013-30", "marketing_start_date": "20230921"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-60)", "package_ndc": "82804-013-60", "marketing_start_date": "20230921"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-90)", "package_ndc": "82804-013-90", "marketing_start_date": "20230921"}], "brand_name": "Bupropion Hydrochloride (XL)", "product_id": "82804-013_80f4a4ef-8190-458d-af2e-5daaf32abc01", "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": "82804-013", "generic_name": "bupropion hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "(XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA206556", "marketing_category": "ANDA", "marketing_start_date": "20160829", "listing_expiration_date": "20261231"}