Humatin Capsule
NDC Package 80725-250-01

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

Package Information

Humatin (paromomycin sulfate) capsules is a medication used to treat a certain parasite infection of the intestines (amebiasis). This formulation utilizes a capsule delivery system. Marketed by Waylis Therapeutics Llc, this product is identified by NDC 80725-250 and is authorized under FDA application ANDA065173.

Identification & Billing

NDC Package Code
80725-250-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
80725-250
11-Digit Billing Format
80725025001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Humatin
Non-Proprietary Name
Paromomycin Sulfate
Substance Name
Paromomycin Sulfate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PAROMOMYCIN SULFATE 250 mg/1
Pharmacologic Class
Antiprotozoal - [EPC] (Established Pharmacologic Class)
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
Waylis Therapeutics Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065173
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-08-2021
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80725-250-01 identifies a specific commercial package of 100 capsule in 1 bottle of Humatin, a human prescription drug labeled by Waylis Therapeutics Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This capsule is formulated for oral 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 Waylis Therapeutics Llc on April 08, 2021. 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 Waylis Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80725025001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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 (5-3-2)
80725-250-01
11-Digit CMS (5-4-2)
80725-0250-01

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