bupropion hydrochloride xl (72516-035)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride xl

Generic Name bupropion hydrochloride

Labeler oryza pharmaceuticals inc.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer

Oryza pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72516-035

Product ID 72516-035_47afeb95-a677-8969-e063-6294a90a7b2d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211200

Listing Expiration 2027-12-31

Marketing Start 2020-10-01

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 72516035

Hyphenated Format 72516-035

Supplemental Identifiers

RxCUI

993541 993557

UPC

0372516036096 0372516036508 0372516035037 0372516035099 0372516035501 0372516036034

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 ANDA211200 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

150 mg/1

source: ndc

Packaging

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-03)
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-09)
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-50)

source: ndc

Packages (3)

72516-035-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-03) 72516-035-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-09) 72516-035-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-50)

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": "47afeb95-a677-8969-e063-6294a90a7b2d", "openfda": {"upc": ["0372516036096", "0372516036508", "0372516035037", "0372516035099", "0372516035501", "0372516036034"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["004d8121-59d4-46c4-acb8-b2dd097bf556"], "manufacturer_name": ["Oryza pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-03)", "package_ndc": "72516-035-03", "marketing_start_date": "20201001"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-09)", "package_ndc": "72516-035-09", "marketing_start_date": "20201001"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-035-50)", "package_ndc": "72516-035-50", "marketing_start_date": "20201001"}], "brand_name": "buPropion Hydrochloride XL", "product_id": "72516-035_47afeb95-a677-8969-e063-6294a90a7b2d", "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": "72516-035", "generic_name": "bupropion hydrochloride", "labeler_name": "Oryza pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "buPropion Hydrochloride", "brand_name_suffix": "XL", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA211200", "marketing_category": "ANDA", "marketing_start_date": "20201001", "listing_expiration_date": "20271231"}