bumetanide

Generic: bumetanide

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bumetanide
Generic Name bumetanide
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

bumetanide .25 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-570
Product ID 65219-570_aaff61c4-203b-4905-9138-0f98959ad013
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216434
Listing Expiration 2026-12-31
Marketing Start 2022-09-26

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 65219570
Hyphenated Format 65219-570

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 ANDA216434 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-570-04) / 4 mL in 1 VIAL, SINGLE-DOSE (65219-570-01)
source: ndc

Packages (1)

65219-570-04 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-570-04) / 4 mL in 1 VIAL, SINGLE-DOSE (65219-570-01)

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": "aaff61c4-203b-4905-9138-0f98959ad013", "openfda": {"nui": ["N0000175366", "N0000175590"], "unii": ["0Y2S3XUQ5H"], "rxcui": ["282486", "1727569"], "spl_set_id": ["a007f3aa-3977-4be3-a9a2-db3d458bca58"], "pharm_class_pe": ["Increased Diuresis at Loop of Henle [PE]"], "pharm_class_epc": ["Loop Diuretic [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (65219-570-04)  / 4 mL in 1 VIAL, SINGLE-DOSE (65219-570-01)", "package_ndc": "65219-570-04", "marketing_start_date": "20220926"}], "brand_name": "Bumetanide", "product_id": "65219-570_aaff61c4-203b-4905-9138-0f98959ad013", "dosage_form": "INJECTION", "pharm_class": ["Increased Diuresis at Loop of Henle [PE]", "Loop Diuretic [EPC]"], "product_ndc": "65219-570", "generic_name": "Bumetanide", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bumetanide", "active_ingredients": [{"name": "BUMETANIDE", "strength": ".25 mg/mL"}], "application_number": "ANDA216434", "marketing_category": "ANDA", "marketing_start_date": "20220926", "listing_expiration_date": "20261231"}