Paromomycin Sulfate Powder
NDC Package 86184-301-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Paromomycin Sulfate powders is a medication used to treat a certain parasite infection of the intestines (amebiasis). This formulation utilizes a powder delivery system. Marketed by Maeda Inc, this product is identified by NDC 86184-301.

Identification & Billing

NDC Package Code
86184-301-01
Package Description
1 g in 1 PACKAGE
Product Code
86184-301
11-Digit Billing Format
86184030101

Clinical Specifications

Proprietary Name
Paromomycin Sulfate
Non-Proprietary Name
Paromomycin Sulfate
Substance Name
Paromomycin Sulfate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
PAROMOMYCIN SULFATE 1 g/g
Usage Information
This medication is used to treat a certain parasite infection of the intestines (amebiasis). This medication is known as an aminoglycoside antibiotic. It works by stopping the growth of parasites in the intestines. This medication is poorly absorbed into the blood so it will not work for infections outside of the intestines. Paromomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition occurs in people with liver disease and is caused by too much of a certain natural substance (ammonia) in the body. Normally the liver gets rid of the ammonia. Paromomycin helps to treat hepatic encephalopathy by stopping the growth of certain bacteria in your intestines that make ammonia. This antibiotic treats only parasitic and bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Maeda Inc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
08-20-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 86184-301-01 identifies a specific commercial package of 1 g in 1 package of Paromomycin Sulfate (UNFINISHED drug), a bulk ingredient labeled by Maeda Inc. This powder is formulated for use and contains paromomycin 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 Maeda Inc on August 20, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain parasite infection of the intestines (amebiasis). This medication is known as an aminoglycoside antibiotic. It works by stopping the growth of parasites in the intestines. This medication is poorly absorbed into the blood so it will not work for infections outside of the intestines. Paromomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition occurs in people with liver disease and is caused by too much of a certain natural substance (ammonia) in the body. Normally the liver gets rid of the ammonia. Paromomycin helps to treat hepatic encephalopathy by stopping the growth of certain bacteria in your intestines that make ammonia. This antibiotic treats only parasitic and bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this Maeda Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 86184030101. 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 (5-3-2)
86184-301-01
11-Digit CMS (5-4-2)
86184-0301-01

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