bupropion hydrochloride

Generic: bupropion hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride
Generic Name bupropion hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

bupropion hydrochloride 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4218
Product ID 70518-4218_47e30df7-831d-2c9d-e063-6294a90a8266
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203013
Listing Expiration 2027-12-31
Marketing Start 2024-10-21

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 705184218
Hyphenated Format 70518-4218

Supplemental Identifiers

RxCUI
993687
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 ANDA203013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4218-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4218-1)
source: ndc

Packages (2)

70518-4218-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4218-0) 70518-4218-1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4218-1)

Ingredients (1)

bupropion hydrochloride (100 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": "47e30df7-831d-2c9d-e063-6294a90a8266", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993687"], "spl_set_id": ["990587bd-4c7d-4a36-8a38-3104648ab3a2"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4218-0)", "package_ndc": "70518-4218-0", "marketing_start_date": "20241021"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4218-1)", "package_ndc": "70518-4218-1", "marketing_start_date": "20260108"}], "brand_name": "Bupropion Hydrochloride", "product_id": "70518-4218_47e30df7-831d-2c9d-e063-6294a90a8266", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "70518-4218", "generic_name": "Bupropion Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA203013", "marketing_category": "ANDA", "marketing_start_date": "20241021", "listing_expiration_date": "20271231"}