bupropion hydrochloride xl (42806-414)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride xl

Generic Name bupropion hydrochloride

Labeler epic pharma, llc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer

Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-414

Product ID 42806-414_4bde5d2f-85ee-95da-e063-6394a90aab81

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA210015

Listing Expiration 2027-12-31

Marketing Start 2023-04-30

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 42806414

Hyphenated Format 42806-414

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 ANDA210015 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

150 mg/1

source: ndc

Packaging

500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-414-05)
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-414-09)
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-414-30)

source: ndc

Packages (3)

42806-414-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-414-05) 42806-414-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-414-09) 42806-414-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-414-30)

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": "4bde5d2f-85ee-95da-e063-6394a90aab81", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["f79d1422-a9b6-41c2-a46d-22886605f94d"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-414-05)", "package_ndc": "42806-414-05", "marketing_start_date": "20230430"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-414-09)", "package_ndc": "42806-414-09", "marketing_start_date": "20230430"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42806-414-30)", "package_ndc": "42806-414-30", "marketing_start_date": "20230430"}], "brand_name": "Bupropion Hydrochloride XL", "product_id": "42806-414_4bde5d2f-85ee-95da-e063-6394a90aab81", "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": "42806-414", "generic_name": "bupropion hydrochloride", "labeler_name": "Epic Pharma, LLC", "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": "ANDA210015", "marketing_category": "ANDA", "marketing_start_date": "20230430", "listing_expiration_date": "20271231"}