bupropion hydrochloride

Generic: bupropion hydrochloride

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

Drug Facts

Product Profile

Brand Name bupropion hydrochloride
Generic Name bupropion hydrochloride
Labeler accord healthcare inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-444
Product ID 16729-444_4092a3ea-403d-7a91-e063-6394a90a8ddf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210497
Listing Expiration 2026-12-31
Marketing Start 2019-03-25

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 16729444
Hyphenated Format 16729-444

Supplemental Identifiers

RxCUI
993541 993557
UPC
0316729444101 0316729443104
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 ANDA210497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-10)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-16)
source: ndc

Packages (2)

16729-444-10 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-10) 16729-444-16 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-16)

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": "4092a3ea-403d-7a91-e063-6394a90a8ddf", "openfda": {"upc": ["0316729444101", "0316729443104"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["34686e9d-c106-4276-8b47-7460cca8860e"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-10)", "package_ndc": "16729-444-10", "marketing_start_date": "20190325"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-444-16)", "package_ndc": "16729-444-16", "marketing_start_date": "20190325"}], "brand_name": "BUPROPION HYDROCHLORIDE", "product_id": "16729-444_4092a3ea-403d-7a91-e063-6394a90a8ddf", "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": "16729-444", "generic_name": "BUPROPION HYDROCHLORIDE", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPROPION HYDROCHLORIDE", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA210497", "marketing_category": "ANDA", "marketing_start_date": "20190325", "listing_expiration_date": "20261231"}