bumetanide

Generic: bumetanide

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bumetanide
Generic Name bumetanide
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bumetanide 1 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-0541
Product ID 0832-0541_d53166d9-64ca-4b76-81a7-b70a60c53b12
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209916
Marketing Start 2018-01-30
Marketing End 2026-09-30

Pharmacologic Class

Established (EPC)
loop diuretic [epc]
Physiologic Effect
increased diuresis at loop of henle [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08320541
Hyphenated Format 0832-0541

Supplemental Identifiers

RxCUI
197417 197418 197419
UPC
0308320540115 0308320541112
UNII
0Y2S3XUQ5H
NUI
N0000175366 N0000175590

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 bumetanide (source: ndc)
Generic Name bumetanide (source: ndc)
Application Number ANDA209916 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (0832-0541-10)
  • 100 TABLET in 1 BOTTLE (0832-0541-11)
source: ndc

Packages (2)

0832-0541-10 1000 TABLET in 1 BOTTLE (0832-0541-10) 0832-0541-11 100 TABLET in 1 BOTTLE (0832-0541-11)

Ingredients (1)

bumetanide (1 mg/1)

Linked Drug Pages (1)

Bumetanide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d53166d9-64ca-4b76-81a7-b70a60c53b12", "openfda": {"nui": ["N0000175366", "N0000175590"], "upc": ["0308320540115", "0308320541112"], "unii": ["0Y2S3XUQ5H"], "rxcui": ["197417", "197418", "197419"], "spl_set_id": ["ff5dc8c6-b2f2-41d3-8e56-a953aa721b59"], "pharm_class_pe": ["Increased Diuresis at Loop of Henle [PE]"], "pharm_class_epc": ["Loop Diuretic [EPC]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (0832-0541-10)", "package_ndc": "0832-0541-10", "marketing_end_date": "20260930", "marketing_start_date": "20180130"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (0832-0541-11)", "package_ndc": "0832-0541-11", "marketing_end_date": "20260930", "marketing_start_date": "20180130"}], "brand_name": "Bumetanide", "product_id": "0832-0541_d53166d9-64ca-4b76-81a7-b70a60c53b12", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis at Loop of Henle [PE]", "Loop Diuretic [EPC]"], "product_ndc": "0832-0541", "generic_name": "BUMETANIDE", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bumetanide", "active_ingredients": [{"name": "BUMETANIDE", "strength": "1 mg/1"}], "application_number": "ANDA209916", "marketing_category": "ANDA", "marketing_end_date": "20260930", "marketing_start_date": "20180130"}