bupropion hydrochloride (85534-0006)

Drug Facts

Product Profile

Brand Name bupropion hydrochloride

Generic Name bupropion hydrochloride

Labeler hawaii repack, inc.

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer

HAWAII REPACK, INC.

Identifiers & Regulatory

Product NDC 85534-0006

Product ID 85534-0006_3745abec-26fc-d50e-e063-6294a90a037d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA077285

Listing Expiration 2026-12-31

Marketing Start 2015-02-17

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 855340006

Hyphenated Format 85534-0006

Supplemental Identifiers

RxCUI

993557

UNII

ZG7E5POY8O

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 ANDA077285 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1

source: ndc

Packaging

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-1)
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-3)
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-5)
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-6)
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-9)

source: ndc

Packages (5)

85534-0006-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-1) 85534-0006-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-3) 85534-0006-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-5) 85534-0006-6 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-6) 85534-0006-9 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-9)

Ingredients (1)

bupropion hydrochloride (300 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": "3745abec-26fc-d50e-e063-6294a90a037d", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993557"], "spl_set_id": ["b4a1d3b8-afcf-47e3-96d3-469d8f408a31"], "manufacturer_name": ["HAWAII REPACK, INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-1)", "package_ndc": "85534-0006-1", "marketing_start_date": "20250611"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-3)", "package_ndc": "85534-0006-3", "marketing_start_date": "20250611"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-5)", "package_ndc": "85534-0006-5", "marketing_start_date": "20250611"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-6)", "package_ndc": "85534-0006-6", "marketing_start_date": "20250611"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (85534-0006-9)", "package_ndc": "85534-0006-9", "marketing_start_date": "20250611"}], "brand_name": "Bupropion Hydrochloride", "product_id": "85534-0006_3745abec-26fc-d50e-e063-6294a90a037d", "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": "85534-0006", "generic_name": "Bupropion Hydrochloride", "labeler_name": "HAWAII REPACK, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA077285", "marketing_category": "ANDA", "marketing_start_date": "20150217", "listing_expiration_date": "20261231"}