Bumetanide Injection
NDC Package 83301-0080-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Bumetanide injection is bumetanide is used to reduce extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, and kidney disease. This formulation utilizes a injection delivery system. Marketed by Mullan Pharmaceutical Inc., this product is identified by NDC 83301-0080 and is authorized under FDA application ANDA219116.

Identification & Billing

NDC Package Code
83301-0080-2
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE (83301-0080-1)
Product Code
83301-0080
11-Digit Billing Format
83301008002
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bumetanide
Non-Proprietary Name
Bumetanide
Substance Name
Bumetanide
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
BUMETANIDE .25 mg/mL
Pharmacologic Class
Usage Information
Bumetanide is used to reduce extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, and kidney disease. This can lessen symptoms such as shortness of breath and swelling in your arms, legs, and abdomen. Bumetanide is a "water pill" (diuretic) that causes you to make more urine. This helps your body get rid of extra water and salt.

Regulatory & Marketing

Labeler Name
Mullan Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA219116
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-12-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83301-0080-2 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 4 ml in 1 vial, single-dose (83301-0080-1) of Bumetanide, a human prescription drug labeled by Mullan Pharmaceutical Inc.. This injection is formulated for intramuscular; intravenous use and contains bumetanide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Mullan Pharmaceutical Inc. on August 12, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Bumetanide is used to reduce extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, and kidney disease. This can lessen symptoms such as shortness of breath and swelling in your arms, legs, and abdomen. Bumetanide is a "water pill" (diuretic) that causes you to make more urine. This helps your body get rid of extra water and salt.

How is this Mullan Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83301008002. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
83301-0080-2
11-Digit CMS (5-4-2)
83301-0080-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.