bupropion hydrochloride sr

Generic: bupropion hydrochloride

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

Drug Facts

Product Profile

Brand Name bupropion hydrochloride sr
Generic Name bupropion hydrochloride
Labeler epic pharma, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 100 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-424
Product ID 42806-424_4bde570a-dab5-a156-e063-6394a90a4287
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211347
Listing Expiration 2027-12-31
Marketing Start 2023-09-18

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 42806424
Hyphenated Format 42806-424

Supplemental Identifiers

RxCUI
993503 993518 993536
UPC
0342806426050 0342806426012 0342806425053 0342806425015 0342806424056 0342806424605 0342806426609 0342806424018
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 sr (source: ndc)
Generic Name bupropion hydrochloride (source: ndc)
Application Number ANDA211347 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-05)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-60)
source: ndc

Packages (3)

42806-424-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-01) 42806-424-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-05) 42806-424-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-60)

Ingredients (1)

bupropion hydrochloride (100 mg/1)

Linked Drug Pages (1)

Bupropion Hydrochloride SR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4bde570a-dab5-a156-e063-6394a90a4287", "openfda": {"upc": ["0342806426050", "0342806426012", "0342806425053", "0342806425015", "0342806424056", "0342806424605", "0342806426609", "0342806424018"], "unii": ["ZG7E5POY8O"], "rxcui": ["993503", "993518", "993536"], "spl_set_id": ["f8ad76a2-9f75-4660-973d-34402f314e9c"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-01)", "package_ndc": "42806-424-01", "marketing_start_date": "20230918"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-05)", "package_ndc": "42806-424-05", "marketing_start_date": "20230918"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-60)", "package_ndc": "42806-424-60", "marketing_start_date": "20230918"}], "brand_name": "Bupropion Hydrochloride SR", "product_id": "42806-424_4bde570a-dab5-a156-e063-6394a90a4287", "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": "42806-424", "generic_name": "bupropion hydrochloride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "SR", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA211347", "marketing_category": "ANDA", "marketing_start_date": "20230918", "listing_expiration_date": "20271231"}