Impavido Capsule
NDC Package 69051-300-01

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Impavido (miltefosine) capsules is miltefosine is used to treat a certain infection called leishmaniasis. This formulation utilizes a capsule delivery system. Marketed by Profounda, Inc., this product is identified by NDC 69051-300 and is authorized under FDA application NDA204684.

Identification & Billing

NDC Package Code
69051-300-01
Package Description
2 BLISTER PACK in 1 CARTON / 14 CAPSULE in 1 BLISTER PACK
Product Code
69051-300
11-Digit Billing Format
69051030001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk

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
Profounda, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA204684
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-29-2015
End Marketing Date
09-26-2026
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 69051-300-01 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 Profounda, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. 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 Profounda, Inc. on October 29, 2015.

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 Profounda, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69051030001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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)
69051-300-01
11-Digit CMS (5-4-2)
69051-0300-01

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