bupropion hydrochloride

Generic: bupropion hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride
Generic Name bupropion hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 200 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-5445
Product ID 0115-5445_cb660c34-cfd0-4598-a767-db8a82e087e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076711
Listing Expiration 2026-12-31
Marketing Start 2004-12-03

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 01155445
Hyphenated Format 0115-5445

Supplemental Identifiers

RxCUI
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 ANDA076711 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-5445-13)
source: ndc

Packages (1)

0115-5445-13 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-5445-13)

Ingredients (1)

bupropion hydrochloride (200 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": "cb660c34-cfd0-4598-a767-db8a82e087e0", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993536"], "spl_set_id": ["e962fb9a-d9fb-49c5-a8b4-0b355b8f829b"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-5445-13)", "package_ndc": "0115-5445-13", "marketing_start_date": "20041203"}], "brand_name": "Bupropion Hydrochloride", "product_id": "0115-5445_cb660c34-cfd0-4598-a767-db8a82e087e0", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "0115-5445", "generic_name": "BUPROPION HYDROCHLORIDE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA076711", "marketing_category": "ANDA", "marketing_start_date": "20041203", "listing_expiration_date": "20261231"}