bupropion hydrochloride

Generic: bupropion hydrochloride

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

Drug Facts

Product Profile

Brand Name bupropion hydrochloride
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 42806-415
Product ID 42806-415_af1a3522-8180-4e3f-a2fc-c9fe143997a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075932
Listing Expiration 2026-12-31
Marketing Start 2021-12-15

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 42806415
Hyphenated Format 42806-415

Supplemental Identifiers

RxCUI
993503 993518 993536
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 (source: ndc)
Generic Name bupropion hydrochloride (source: ndc)
Application Number ANDA075932 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-05)
  • 250 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-52)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-60)
source: ndc

Packages (4)

42806-415-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-01) 42806-415-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-05) 42806-415-52 250 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-52) 42806-415-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-60)

Ingredients (1)

bupropion hydrochloride (150 mg/1)

Linked Drug Pages (1)

BUPROPION HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "af1a3522-8180-4e3f-a2fc-c9fe143997a3", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993503", "993518", "993536"], "spl_set_id": ["9fb44e96-6160-4a4a-90cb-91764c0dcd89"], "manufacturer_name": ["Epic Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-01)", "package_ndc": "42806-415-01", "marketing_start_date": "20211215"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-05)", "package_ndc": "42806-415-05", "marketing_start_date": "20211215"}, {"sample": false, "description": "250 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-52)", "package_ndc": "42806-415-52", "marketing_start_date": "20211215"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-415-60)", "package_ndc": "42806-415-60", "marketing_start_date": "20211215"}], "brand_name": "BUPROPION HYDROCHLORIDE", "product_id": "42806-415_af1a3522-8180-4e3f-a2fc-c9fe143997a3", "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": "42806-415", "generic_name": "BUPROPION HYDROCHLORIDE", "labeler_name": "Epic Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPROPION HYDROCHLORIDE", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA075932", "marketing_category": "ANDA", "marketing_start_date": "20211215", "listing_expiration_date": "20261231"}