Impavido Capsule
NDC Package 71863-135-28

11-digit billing NDC: 71863013528
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Impavido (miltefosine) capsules is miltefosine is used to treat a certain infection called leishmaniasis. This formulation utilizes a capsule delivery system. Marketed by Eton Pharmaceuticals, Inc., this product is identified by NDC 71863-135 and is authorized under FDA application NDA204684.

Identification & Billing

NDC Package Code
71863-135-28
Package Description
2 BLISTER PACK in 1 CARTON / 14 CAPSULE in 1 BLISTER PACK
Product Code
71863-135
11-Digit Billing Format
71863013528

Clinical Specifications

Proprietary Name
Impavido
Non-Proprietary Name
Miltefosine
Substance Name
Miltefosine
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)
MILTEFOSINE 50 mg/1
Pharmacologic Class
Antileishmanial - [EPC] (Established Pharmacologic Class)
Usage Information
Miltefosine is used to treat a certain infection called leishmaniasis. It works by stopping the growth of certain parasites.

Regulatory & Marketing

Labeler Name
Eton Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA204684
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-26-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71863-135-28 identifies a specific commercial package of 2 blister pack in 1 carton / 14 capsule in 1 blister pack of Impavido, a human prescription drug labeled by Eton Pharmaceuticals, Inc.. This capsule is formulated for oral use and contains miltefosine 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 Eton Pharmaceuticals, Inc. on September 26, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Miltefosine is used to treat a certain infection called leishmaniasis. It works by stopping the growth of certain parasites.

How is this Eton Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71863013528. 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)
71863-135-28
11-Digit CMS (5-4-2)
71863-0135-28

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