Actimmune
NDC Package 42238-111-12

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.

Actimmune is a medication used to reduce the frequency and severity of serious infections due to chronic granulomatous disease, a disorder that runs in families. Marketed by Hznp Usa, Inc., this product is identified by NDC 42238-111 and is authorized under FDA application BLA103836.

Identification & Billing

NDC Package Code
42238-111-12
Package Description
12 VIAL, SINGLE-USE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-USE (42238-111-01)
Product Code
42238-111
11-Digit Billing Format
42238011112
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Actimmune
Dosage Form
-
Usage Information
This medication is used to reduce the frequency and severity of serious infections due to chronic granulomatous disease, a disorder that runs in families. This drug is often used along with antibiotics to help prevent these serious infections. This medication is also used to slow the worsening of malignant osteopetrosis, another disorder that runs in families, that affects bones, nerves, and blood. This medication is the same as a protein that your body naturally produces (interferon). In the body, it is thought to work by affecting cell function/growth and the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off serious infections.

Regulatory & Marketing

Labeler Name
Hznp Usa, Inc.
FDA Application #
BLA103836
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-01-2013
End Marketing Date
01-17-2018
Listing Expiration
01-17-2018
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 42238-111-12 identifies a specific commercial package of 12 vial, single-use in 1 carton / .5 ml in 1 vial, single-use (42238-111-01) of Actimmune, labeled by Hznp Usa, Inc.. 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 Hznp Usa, Inc. on December 01, 2013. The current certification is valid through January 17, 2018.

What are the primary indications for this medication?

This medication is used to reduce the frequency and severity of serious infections due to chronic granulomatous disease, a disorder that runs in families. This drug is often used along with antibiotics to help prevent these serious infections. This medication is also used to slow the worsening of malignant osteopetrosis, another disorder that runs in families, that affects bones, nerves, and blood. This medication is the same as a protein that your body naturally produces (interferon). In the body, it is thought to work by affecting cell function/growth and the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off serious infections.

How is this Hznp Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42238011112. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
42238-111-12
11-Digit CMS (5-4-2)
42238-0111-12

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