Gentamicin Sulfate In Sodium Chloride Injection, Solution
NDC Package 0338-0505-48

11-digit billing NDC: 00338050548 · Billing unit: ML · 100 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Gentamicin Sulfate In Sodium Chloride (gentamicin sulfate) injection is to reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a injection, solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-0505 and is authorized under FDA application ANDA062373.

Identification & Billing

NDC Package Code
0338-0505-48
Package Description
100 mL in 1 BAG
Product Code
0338-0505
11-Digit Billing Format
00338050548
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gentamicin Sulfate In Sodium Chloride
Non-Proprietary Name
Gentamicin Sulfate
Substance Name
Gentamicin Sulfate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GENTAMICIN SULFATE 100 mg/100mL
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride Injection 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.Gentamicin Sulfate in 0.9% Sodium Chloride Injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter- Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative). Clinical studies have shown gentamicin sulfate to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity.Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin.Gentamicin Sulfate in 0.9% Sodium Chloride Injection may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the boxed WARNINGS. If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted. In serious infections when the causative organisms are unknown, Gentamicin Sulfate in 0.9% Sodium Chloride Injection may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.Gentamicin injection has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci. Gentamicin injection has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgement indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms.In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin (see PRECAUTIONS, Pediatric Use and DOSAGE AND ADMINISTRATION sections).

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA062373
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-07-1982
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.

J1580
Source: ASP
Garamycin gentamicin inj
HCPCS Dosage UP TO 80 MG
Units / Pkg 2

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 0338-0505-48 identifies a specific commercial package of 100 ml in 1 bag of Gentamicin Sulfate In Sodium Chloride, a human prescription drug labeled by Baxter Healthcare Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. This injection, solution is formulated for intravenous use and contains gentamicin 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 Baxter Healthcare Corporation on September 07, 1982. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338050548. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 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 (4-4-2)
0338-0505-48
11-Digit CMS (5-4-2)
00338-0505-48

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