Gentamicin Sulfate In Sodium Chloride Injection, Solution
NDC Package 0338-0507-41

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Gentamicin Sulfate In Sodium Chloride (gentamicin sulfate) injection is a medication used to treat bacterial infections (such as blepharitis, conjunctivitis) of the eye and the skin around the eyes (such as eyelids). This formulation utilizes a injection, solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-0507 and is authorized under FDA application ANDA062373.

Identification & Billing

NDC Package Code
0338-0507-41
Package Description
50 mL in 1 BAG
Product Code
0338-0507
11-Digit Billing Format
00338050741
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
50 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 60 mg/50mL
Pharmacologic Class
Usage Information
This medication is used to treat bacterial infections (such as blepharitis, conjunctivitis) of the eye and the skin around the eyes (such as eyelids). It is also used to prevent infection after eye injury or surgery. It belongs to a class of drugs known as aminoglycoside antibiotics. Gentamicin works by killing the bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

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: PDAC
INJECTION, GARAMYCIN, GENTAMICIN, UP TO 80 MG
HCPCS Dosage 80 MG
Units / Pkg

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0338-0507). Click a package code to view its specific billing and regulatory data.

0338-0507-48
100 mL in 1 BAG

* 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 0338-0507-41 identifies a specific commercial package of 50 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 50 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.

What are the primary indications for this medication?

This medication is used to treat bacterial infections (such as blepharitis, conjunctivitis) of the eye and the skin around the eyes (such as eyelids). It is also used to prevent infection after eye injury or surgery. It belongs to a class of drugs known as aminoglycoside antibiotics. Gentamicin works by killing the bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338050741. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 50 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)
0338-0507-41
11-Digit CMS (5-4-2)
00338-0507-41

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