bumetanide

Generic: bumetanide

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

Drug Facts

Product Profile

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

bumetanide .25 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-323
Product ID 70748-323_39d376d9-2fab-40d3-8592-668c5083a0c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217153
Listing Expiration 2026-12-31
Marketing Start 2024-11-11

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 70748323
Hyphenated Format 70748-323

Supplemental Identifiers

RxCUI
282486 1727569
UPC
0370748323014 0370748323021
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 ANDA217153 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (70748-323-10) / 4 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (70748-323-11) / 10 mL in 1 VIAL
source: ndc

Packages (2)

70748-323-10 10 VIAL in 1 CARTON (70748-323-10) / 4 mL in 1 VIAL 70748-323-11 10 VIAL in 1 CARTON (70748-323-11) / 10 mL in 1 VIAL

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": "39d376d9-2fab-40d3-8592-668c5083a0c9", "openfda": {"nui": ["N0000175366", "N0000175590"], "upc": ["0370748323014", "0370748323021"], "unii": ["0Y2S3XUQ5H"], "rxcui": ["282486", "1727569"], "spl_set_id": ["2c71a17e-ed76-4545-b23e-9f4997b13c2f"], "pharm_class_pe": ["Increased Diuresis at Loop of Henle [PE]"], "pharm_class_epc": ["Loop Diuretic [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (70748-323-10)  / 4 mL in 1 VIAL", "package_ndc": "70748-323-10", "marketing_start_date": "20241111"}, {"sample": false, "description": "10 VIAL in 1 CARTON (70748-323-11)  / 10 mL in 1 VIAL", "package_ndc": "70748-323-11", "marketing_start_date": "20241111"}], "brand_name": "BUMETANIDE", "product_id": "70748-323_39d376d9-2fab-40d3-8592-668c5083a0c9", "dosage_form": "INJECTION", "pharm_class": ["Increased Diuresis at Loop of Henle [PE]", "Loop Diuretic [EPC]"], "product_ndc": "70748-323", "generic_name": "Bumetanide", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUMETANIDE", "active_ingredients": [{"name": "BUMETANIDE", "strength": ".25 mg/mL"}], "application_number": "ANDA217153", "marketing_category": "ANDA", "marketing_start_date": "20241111", "listing_expiration_date": "20261231"}