bupropion hydrochloride xl

Generic: bupropion hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 300 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-349
Product ID 42806-349_b271a757-875d-4349-8c40-a047c10cbd1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207224
Listing Expiration 2026-12-31
Marketing Start 2017-10-01

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 42806349
Hyphenated Format 42806-349

Supplemental Identifiers

RxCUI
993541 993557
UPC
0342806349090
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 ANDA207224 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-349-05)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-349-09)
source: ndc

Packages (2)

42806-349-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-349-05) 42806-349-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-349-09)

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": "b271a757-875d-4349-8c40-a047c10cbd1b", "openfda": {"upc": ["0342806349090"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["178c7129-a752-4ad9-ac82-4473e23bbacc"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-349-05)", "package_ndc": "42806-349-05", "marketing_start_date": "20171001"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-349-09)", "package_ndc": "42806-349-09", "marketing_start_date": "20171001"}], "brand_name": "Bupropion Hydrochloride XL", "product_id": "42806-349_b271a757-875d-4349-8c40-a047c10cbd1b", "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": "42806-349", "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": "300 mg/1"}], "application_number": "ANDA207224", "marketing_category": "ANDA", "marketing_start_date": "20171001", "listing_expiration_date": "20261231"}