bupropion hydrochloride xl

Generic: bupropion hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hydrochloride xl
Generic Name bupropion hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 150 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-080
Product ID 82804-080_dfd5f264-d4fd-4441-88b1-48086c7c0616
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210015
Listing Expiration 2026-12-31
Marketing Start 2023-04-30

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 82804080
Hyphenated Format 82804-080

Supplemental Identifiers

RxCUI
993541
UPC
0382804080908
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 xl (source: ndc)
Generic Name bupropion hydrochloride (source: ndc)
Application Number ANDA210015 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-90)
source: ndc

Packages (3)

82804-080-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-30) 82804-080-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-60) 82804-080-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-90)

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": "dfd5f264-d4fd-4441-88b1-48086c7c0616", "openfda": {"upc": ["0382804080908"], "unii": ["ZG7E5POY8O"], "rxcui": ["993541"], "spl_set_id": ["dfd5f264-d4fd-4441-88b1-48086c7c0616"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-30)", "package_ndc": "82804-080-30", "marketing_start_date": "20240305"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-60)", "package_ndc": "82804-080-60", "marketing_start_date": "20240305"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-080-90)", "package_ndc": "82804-080-90", "marketing_start_date": "20240305"}], "brand_name": "Bupropion Hydrochloride XL", "product_id": "82804-080_dfd5f264-d4fd-4441-88b1-48086c7c0616", "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": "82804-080", "generic_name": "bupropion hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion Hydrochloride", "brand_name_suffix": "XL", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA210015", "marketing_category": "ANDA", "marketing_start_date": "20230430", "listing_expiration_date": "20261231"}