bumetanide

Generic: bumetanide

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bumetanide
Generic Name bumetanide
Labeler exelan pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bumetanide 1 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-798
Product ID 76282-798_04a4ac27-f6b7-4a88-899b-93a5a21ddb6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212931
Listing Expiration 2027-12-31
Marketing Start 2025-03-01

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 76282798
Hyphenated Format 76282-798

Supplemental Identifiers

RxCUI
197417 197418 197419
UPC
0376282798059 0376282797014 0376282798011 0376282799056 0376282799018
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 ANDA212931 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76282-798-01)
  • 500 TABLET in 1 BOTTLE (76282-798-05)
source: ndc

Packages (2)

76282-798-01 100 TABLET in 1 BOTTLE (76282-798-01) 76282-798-05 500 TABLET in 1 BOTTLE (76282-798-05)

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": "04a4ac27-f6b7-4a88-899b-93a5a21ddb6e", "openfda": {"nui": ["N0000175366", "N0000175590"], "upc": ["0376282798059", "0376282797014", "0376282798011", "0376282799056", "0376282799018"], "unii": ["0Y2S3XUQ5H"], "rxcui": ["197417", "197418", "197419"], "spl_set_id": ["06745425-e7e7-4413-b9ff-22b121f0ea9a"], "pharm_class_pe": ["Increased Diuresis at Loop of Henle [PE]"], "pharm_class_epc": ["Loop Diuretic [EPC]"], "manufacturer_name": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76282-798-01)", "package_ndc": "76282-798-01", "marketing_start_date": "20250301"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76282-798-05)", "package_ndc": "76282-798-05", "marketing_start_date": "20250301"}], "brand_name": "Bumetanide", "product_id": "76282-798_04a4ac27-f6b7-4a88-899b-93a5a21ddb6e", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis at Loop of Henle [PE]", "Loop Diuretic [EPC]"], "product_ndc": "76282-798", "generic_name": "Bumetanide", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bumetanide", "active_ingredients": [{"name": "BUMETANIDE", "strength": "1 mg/1"}], "application_number": "ANDA212931", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20271231"}