bupropion hcl er (xl)

Generic: bupropion hcl er (xl)

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bupropion hcl er (xl)
Generic Name bupropion hcl er (xl)
Labeler direct_rx
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 300 mg/1

Manufacturer
Direct_RX

Identifiers & Regulatory

Product NDC 72189-539
Product ID 72189-539_19b02d9d-9104-0442-e063-6394a90a3154
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210015
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

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 72189539
Hyphenated Format 72189-539

Supplemental Identifiers

RxCUI
993557
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 hcl er (xl) (source: ndc)
Generic Name bupropion hcl er (xl) (source: ndc)
Application Number ANDA210015 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-30)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-90)
source: ndc

Packages (2)

72189-539-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-30) 72189-539-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-90)

Ingredients (1)

bupropion hydrochloride (300 mg/1)

Linked Drug Pages (1)

Bupropion HCL ER (XL) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "19b02d9d-9104-0442-e063-6394a90a3154", "openfda": {"unii": ["ZG7E5POY8O"], "rxcui": ["993557"], "spl_set_id": ["129ce80c-0333-873e-e063-6394a90a33e0"], "manufacturer_name": ["Direct_RX"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-30)", "package_ndc": "72189-539-30", "marketing_start_date": "20240301"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-90)", "package_ndc": "72189-539-90", "marketing_start_date": "20240301"}], "brand_name": "Bupropion HCL ER (XL)", "product_id": "72189-539_19b02d9d-9104-0442-e063-6394a90a3154", "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": "72189-539", "generic_name": "Bupropion HCL ER (XL)", "labeler_name": "Direct_RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bupropion HCL ER (XL)", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA210015", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}