bupropion hydrochloride sr (42806-425)

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 150 mg/1

Manufacturer

Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-425

Product ID 42806-425_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 42806425

Hyphenated Format 42806-425

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

150 mg/1

source: ndc

Packaging

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-01)
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-05)
250 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-52)
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-60)

source: ndc

Packages (4)

42806-425-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-01) 42806-425-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-05) 42806-425-52 250 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-52) 42806-425-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-60)

Ingredients (1)

bupropion hydrochloride (150 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 (42806-425-01)", "package_ndc": "42806-425-01", "marketing_start_date": "20230918"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-05)", "package_ndc": "42806-425-05", "marketing_start_date": "20230918"}, {"sample": false, "description": "250 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-52)", "package_ndc": "42806-425-52", "marketing_start_date": "20230918"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-425-60)", "package_ndc": "42806-425-60", "marketing_start_date": "20230918"}], "brand_name": "Bupropion Hydrochloride SR", "product_id": "42806-425_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": "42806-425", "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": "150 mg/1"}], "application_number": "ANDA211347", "marketing_category": "ANDA", "marketing_start_date": "20230918", "listing_expiration_date": "20271231"}