bumetanide

Generic: bumetanide

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bumetanide
Generic Name bumetanide
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bumetanide 1 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-526
Product ID 68382-526_58b3bb3b-6096-42fd-aebc-c856c3050071
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202900
Listing Expiration 2026-12-31
Marketing Start 2018-05-01

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 68382526
Hyphenated Format 68382-526

Supplemental Identifiers

RxCUI
197417 197418 197419
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 ANDA202900 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-526-01)
  • 500 TABLET in 1 BOTTLE (68382-526-05)
  • 30 TABLET in 1 BOTTLE (68382-526-06)
  • 1000 TABLET in 1 BOTTLE (68382-526-10)
  • 90 TABLET in 1 BOTTLE (68382-526-16)
source: ndc

Packages (5)

68382-526-01 100 TABLET in 1 BOTTLE (68382-526-01) 68382-526-05 500 TABLET in 1 BOTTLE (68382-526-05) 68382-526-06 30 TABLET in 1 BOTTLE (68382-526-06) 68382-526-10 1000 TABLET in 1 BOTTLE (68382-526-10) 68382-526-16 90 TABLET in 1 BOTTLE (68382-526-16)

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": "58b3bb3b-6096-42fd-aebc-c856c3050071", "openfda": {"nui": ["N0000175366", "N0000175590"], "unii": ["0Y2S3XUQ5H"], "rxcui": ["197417", "197418", "197419"], "spl_set_id": ["525138cd-832a-41d0-84b0-83921b12bd2a"], "pharm_class_pe": ["Increased Diuresis at Loop of Henle [PE]"], "pharm_class_epc": ["Loop Diuretic [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-526-01)", "package_ndc": "68382-526-01", "marketing_start_date": "20180501"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-526-05)", "package_ndc": "68382-526-05", "marketing_start_date": "20180501"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-526-06)", "package_ndc": "68382-526-06", "marketing_start_date": "20180501"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-526-10)", "package_ndc": "68382-526-10", "marketing_start_date": "20180501"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-526-16)", "package_ndc": "68382-526-16", "marketing_start_date": "20180501"}], "brand_name": "bumetanide", "product_id": "68382-526_58b3bb3b-6096-42fd-aebc-c856c3050071", "dosage_form": "TABLET", "pharm_class": ["Increased Diuresis at Loop of Henle [PE]", "Loop Diuretic [EPC]"], "product_ndc": "68382-526", "generic_name": "bumetanide", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bumetanide", "active_ingredients": [{"name": "BUMETANIDE", "strength": "1 mg/1"}], "application_number": "ANDA202900", "marketing_category": "ANDA", "marketing_start_date": "20180501", "listing_expiration_date": "20261231"}