bupropion

Generic: bupropion

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

Drug Facts

Product Profile

Brand Name bupropion
Generic Name bupropion
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-354
Product ID 68382-354_00be046c-e051-4430-a967-3a0d4611da22
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201567
Listing Expiration 2026-12-31
Marketing Start 2014-02-15

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 68382354
Hyphenated Format 68382-354

Supplemental Identifiers

RxCUI
993541 993557
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 (source: ndc)
Generic Name bupropion (source: ndc)
Application Number ANDA201567 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-06)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-10)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-16)
source: ndc

Packages (4)

68382-354-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-05) 68382-354-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-06) 68382-354-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-10) 68382-354-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-16)

Ingredients (1)

bupropion hydrochloride (300 mg/1)

Linked Drug Pages (1)

bupropion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00be046c-e051-4430-a967-3a0d4611da22", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["8d937ca3-3351-40f1-8192-348ba0c68162"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-05)", "package_ndc": "68382-354-05", "marketing_start_date": "20140215"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-06)", "package_ndc": "68382-354-06", "marketing_start_date": "20140215"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-10)", "package_ndc": "68382-354-10", "marketing_start_date": "20140215"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-16)", "package_ndc": "68382-354-16", "marketing_start_date": "20140215"}], "brand_name": "bupropion", "product_id": "68382-354_00be046c-e051-4430-a967-3a0d4611da22", "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": "68382-354", "generic_name": "bupropion", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bupropion", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA201567", "marketing_category": "ANDA", "marketing_start_date": "20140215", "listing_expiration_date": "20261231"}