bupropion hydrochloride

Generic: bupropion hydrochloride

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

Drug Facts

Product Profile

Brand Name bupropion hydrochloride
Generic Name bupropion hydrochloride
Labeler granules pharmaceuticals inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 200 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-127
Product ID 70010-127_4377481d-43ac-f347-e063-6394a90acc90
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218385
Listing Expiration 2026-12-31
Marketing Start 2025-03-31

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 70010127
Hyphenated Format 70010-127

Supplemental Identifiers

RxCUI
993503 993518 993536
UPC
0370010125032 0370010126039 0370010127036
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 ANDA218385 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-03)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-05)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-06)
source: ndc

Packages (3)

70010-127-03 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-03) 70010-127-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-05) 70010-127-06 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-06)

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": "4377481d-43ac-f347-e063-6394a90acc90", "openfda": {"upc": ["0370010125032", "0370010126039", "0370010127036"], "unii": ["ZG7E5POY8O"], "rxcui": ["993503", "993518", "993536"], "spl_set_id": ["61e9cbe3-8211-42f3-b68f-581f56651919"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-03)", "package_ndc": "70010-127-03", "marketing_start_date": "20250331"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-05)", "package_ndc": "70010-127-05", "marketing_start_date": "20250331"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70010-127-06)", "package_ndc": "70010-127-06", "marketing_start_date": "20250331"}], "brand_name": "BUPROPION HYDROCHLORIDE", "product_id": "70010-127_4377481d-43ac-f347-e063-6394a90acc90", "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": "70010-127", "generic_name": "bupropion hydrochloride", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPROPION HYDROCHLORIDE", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA218385", "marketing_category": "ANDA", "marketing_start_date": "20250331", "listing_expiration_date": "20261231"}