bumetanide

Generic: bumetanide

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bumetanide
Generic Name bumetanide
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

bumetanide .25 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6285
Product ID 0641-6285_cbf46236-4090-445f-ad19-fd9d767deecc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079196
Listing Expiration 2026-12-31
Marketing Start 2008-04-30

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 06416285
Hyphenated Format 0641-6285

Supplemental Identifiers

RxCUI
282486 1727569
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 ANDA079196 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0641-6285-10) / 10 mL in 1 VIAL (0641-6285-01)
source: ndc

Packages (1)

0641-6285-10 10 VIAL in 1 CARTON (0641-6285-10) / 10 mL in 1 VIAL (0641-6285-01)

Ingredients (1)

bumetanide (.25 mg/mL)

Linked Drug Pages (1)

Bumetanide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "cbf46236-4090-445f-ad19-fd9d767deecc", "openfda": {"nui": ["N0000175366", "N0000175590"], "unii": ["0Y2S3XUQ5H"], "rxcui": ["282486", "1727569"], "spl_set_id": ["b5a68154-8003-4b80-81e2-e926524fb72c"], "pharm_class_pe": ["Increased Diuresis at Loop of Henle [PE]"], "pharm_class_epc": ["Loop Diuretic [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0641-6285-10)  / 10 mL in 1 VIAL (0641-6285-01)", "package_ndc": "0641-6285-10", "marketing_start_date": "20080430"}], "brand_name": "Bumetanide", "product_id": "0641-6285_cbf46236-4090-445f-ad19-fd9d767deecc", "dosage_form": "INJECTION", "pharm_class": ["Increased Diuresis at Loop of Henle [PE]", "Loop Diuretic [EPC]"], "product_ndc": "0641-6285", "generic_name": "Bumetanide", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bumetanide", "active_ingredients": [{"name": "BUMETANIDE", "strength": ".25 mg/mL"}], "application_number": "ANDA079196", "marketing_category": "ANDA", "marketing_start_date": "20080430", "listing_expiration_date": "20261231"}