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 300 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4343
Product ID 70518-4343_3d84aca4-4ce7-7ecc-e063-6394a90a0360
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211020
Listing Expiration 2026-12-31
Marketing Start 2025-05-19

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 705184343
Hyphenated Format 70518-4343

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 ANDA211020 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4343-0)
source: ndc

Packages (1)

70518-4343-0 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4343-0)

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": "3d84aca4-4ce7-7ecc-e063-6394a90a0360", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993557"], "spl_set_id": ["d087222e-c5e9-4c48-b27f-e2e2944379c8"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4343-0)", "package_ndc": "70518-4343-0", "marketing_start_date": "20250519"}], "brand_name": "bupropion hydrochloride", "product_id": "70518-4343_3d84aca4-4ce7-7ecc-e063-6394a90a0360", "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": "70518-4343", "generic_name": "bupropion hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bupropion hydrochloride", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA211020", "marketing_category": "ANDA", "marketing_start_date": "20250519", "listing_expiration_date": "20261231"}