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, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4081
Product ID 70518-4081_4c99c0d5-3b4e-de4b-e063-6294a90a822c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216800
Listing Expiration 2027-12-31
Marketing Start 2024-05-16

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 705184081
Hyphenated Format 70518-4081

Supplemental Identifiers

RxCUI
993518
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 ANDA216800 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4081-1)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-2)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-3)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-4)
source: ndc

Packages (4)

70518-4081-1 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4081-1) 70518-4081-2 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-2) 70518-4081-3 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-3) 70518-4081-4 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-4)

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": "4c99c0d5-3b4e-de4b-e063-6294a90a822c", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993518"], "spl_set_id": ["6087100f-3ba4-412e-b08d-768d1dcdaf00"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4081-1)", "package_ndc": "70518-4081-1", "marketing_start_date": "20240926"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-2)", "package_ndc": "70518-4081-2", "marketing_start_date": "20250701"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-3)", "package_ndc": "70518-4081-3", "marketing_start_date": "20250701"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-4)", "package_ndc": "70518-4081-4", "marketing_start_date": "20250827"}], "brand_name": "Bupropion hydrochloride", "product_id": "70518-4081_4c99c0d5-3b4e-de4b-e063-6294a90a822c", "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": "70518-4081", "generic_name": "Bupropion hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA216800", "marketing_category": "ANDA", "marketing_start_date": "20240516", "listing_expiration_date": "20271231"}