Amikacin Sulfate Injection
NDC Package 83301-0023-2

11-digit billing NDC: 83301002302 · Billing unit: ML · 40 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Amikacin Sulfate injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonasspecies, Escherichia coli, species of indole-positive and indole-negative Proteus, Providenciaspecies, Klebsiella-Enterobacter-Serratiaspecies, and Acinetobacter( Mima-Herellea) species. This formulation utilizes a injection delivery system. Marketed by Mullan Pharmaceutical Inc., this product is identified by NDC 83301-0023 and is authorized under FDA application ANDA218146.

Identification & Billing

NDC Package Code
83301-0023-2
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE (83301-0023-1)
Product Code
83301-0023
11-Digit Billing Format
83301002302
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
40 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amikacin Sulfate
Non-Proprietary Name
Amikacin Sulfate
Substance Name
Amikacin Sulfate
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)
AMIKACIN SULFATE 250 mg/mL
Pharmacologic Class
Usage Information
Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonasspecies, Escherichia coli, species of indole-positive and indole-negative Proteus, Providenciaspecies, Klebsiella-Enterobacter-Serratiaspecies, and Acinetobacter( Mima-Herellea) species. Clinical studies have shown Amikacin Sulfate Injection to be effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and post-operative infections (including post-vascular surgery). Clinical studies have shown amikacin also to be effective in serious complicated and recurrent urinary tract infections due to these organisms. Aminoglycosides, including Amikacin Sulfate Injection are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.Bacteriologic studies should be performed to identify causative organisms and their susceptibilities to amikacin. Amikacin may be considered as initial therapy in suspected Gram-negative infections and therapy may be instituted before obtaining the results of susceptibility testing. Clinical trials demonstrated that amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa. The decision to continue therapy with the drug should be based on results of the susceptibility tests, the severity of the infection, the response of the patient and the important additional considerations contained in the WARNINGSbox above. Amikacin has also been shown to be effective in staphylococcal infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus, infections due to susceptible strains of staphylococci in patients allergic to other antibiotics, and in mixed staphylococci/Gram-negative infections.In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin-type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci.To reduce the development of drug-resistant bacteria and maintain the effectiveness of amikacin and other antibacterial drugs, amikacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Mullan Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA218146
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-12-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0278
Source: ASP
Amikacin sulfate injection
HCPCS Dosage 100 MG
Units / Pkg 100

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 83301-0023-2 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 4 ml in 1 vial, single-dose (83301-0023-1) of Amikacin Sulfate, a human prescription drug labeled by Mullan Pharmaceutical Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 40 billable units per package. This injection is formulated for intramuscular; intravenous use and contains amikacin sulfate 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 January 12, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83301002302. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 40 total billable units per package. 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)
83301-0023-2
11-Digit CMS (5-4-2)
83301-0023-02

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