bupropion hydrochloride (xl)

Generic: bupropion hydrochloride

Labeler: vitruvias therapeutics
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride (xl)
Generic Name bupropion hydrochloride
Labeler vitruvias therapeutics
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer
Vitruvias Therapeutics

Identifiers & Regulatory

Product NDC 69680-157
Product ID 69680-157_c7d45984-a653-4be6-9b1c-986a553e4e42
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208652
Listing Expiration 2027-12-31
Marketing Start 2023-04-10

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 69680157
Hyphenated Format 69680-157

Supplemental Identifiers

RxCUI
993541 993557
UPC
0369680158921 0369680157900 0369680157924 0369680158303 0369680158938 0369680157306 0369680157931
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 (xl) (source: ndc)
Generic Name bupropion hydrochloride (source: ndc)
Application Number ANDA208652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-90)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-92)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-93)
source: ndc

Packages (4)

69680-157-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-30) 69680-157-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-90) 69680-157-92 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-92) 69680-157-93 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-93)

Ingredients (1)

bupropion hydrochloride (150 mg/1)

Linked Drug Pages (1)

Bupropion hydrochloride (XL) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c7d45984-a653-4be6-9b1c-986a553e4e42", "openfda": {"upc": ["0369680158921", "0369680157900", "0369680157924", "0369680158303", "0369680158938", "0369680157306", "0369680157931"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541", "993557"], "spl_set_id": ["f53704b2-3d3c-47e8-9fd6-a0f5240c0593"], "manufacturer_name": ["Vitruvias Therapeutics"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-30)", "package_ndc": "69680-157-30", "marketing_start_date": "20230410"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-90)", "package_ndc": "69680-157-90", "marketing_start_date": "20230410"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-92)", "package_ndc": "69680-157-92", "marketing_start_date": "20230410"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-157-93)", "package_ndc": "69680-157-93", "marketing_start_date": "20230410"}], "brand_name": "Bupropion hydrochloride (XL)", "product_id": "69680-157_c7d45984-a653-4be6-9b1c-986a553e4e42", "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": "69680-157", "generic_name": "Bupropion hydrochloride", "labeler_name": "Vitruvias Therapeutics", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion hydrochloride (XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA208652", "marketing_category": "ANDA", "marketing_start_date": "20230410", "listing_expiration_date": "20271231"}