Neomycin Sulfate
NDC Package 0904-5941-06

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Neomycin Sulfate is a medication used to decrease the risk of infection after certain intestinal surgeries. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-5941 and is authorized under FDA application ANDA060304.

Identification & Billing

NDC Package Code
0904-5941-06
Package Description
50 TABLET in 1 BOX, UNIT-DOSE
Product Code
0904-5941
11-Digit Billing Format
00904594106

Clinical Specifications

Proprietary Name
Neomycin Sulfate
Dosage Form
-
Usage Information
This medication is used to decrease the risk of infection after certain intestinal surgeries. Neomycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria in the intestines. Neomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition is caused by too much of a certain natural substance (ammonia). Normally, the liver gets rid of ammonia, but liver disease can cause too much ammonia to build up in the body. This medication helps treat encephalopathy by killing certain intestinal bacteria that make ammonia. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Major Pharmaceuticals
FDA Application #
ANDA060304
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-14-2009
End Marketing Date
10-01-2012
Listing Expiration
10-01-2012
Exclude Flag
D
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 0904-5941-06 identifies a specific commercial package of 50 tablet in 1 box, unit-dose of Neomycin Sulfate, labeled by Major Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Major Pharmaceuticals on September 14, 2009. The current certification is valid through October 01, 2012.

What are the primary indications for this medication?

This medication is used to decrease the risk of infection after certain intestinal surgeries. Neomycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria in the intestines. Neomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition is caused by too much of a certain natural substance (ammonia). Normally, the liver gets rid of ammonia, but liver disease can cause too much ammonia to build up in the body. This medication helps treat encephalopathy by killing certain intestinal bacteria that make ammonia. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904594106. 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)
0904-5941-06
11-Digit CMS (5-4-2)
00904-5941-06

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