Extavia
NDC Package 0078-0569-12

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.

Extavia is a medication used to treat multiple sclerosis (MS). Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0569 and is authorized under FDA application BLA125290.

Identification & Billing

NDC Package Code
0078-0569-12
Package Description
15 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (0078-0569-61) * 3 mL in 1 VIAL, SINGLE-USE * 1.2 mL in 1 SYRINGE
Product Code
0078-0569
11-Digit Billing Format
00078056912
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Extavia
Dosage Form
-
Usage Information
This medication is used to treat multiple sclerosis (MS). Interferon is not a cure for MS, but it may help to slow disease worsening and decrease flare-ups of symptoms (such as balance problems, numbness, or weakness).

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
FDA Application #
BLA125290
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-14-2009
End Marketing Date
05-31-2024
Listing Expiration
05-31-2024
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 0078-0569-12 identifies a specific commercial package of 15 blister pack in 1 carton / 1 kit in 1 blister pack (0078-0569-61) * 3 ml in 1 vial, single-use * 1.2 ml in 1 syringe of Extavia, labeled by Novartis Pharmaceuticals Corporation. 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 Novartis Pharmaceuticals Corporation on August 14, 2009. The current certification is valid through May 31, 2024.

What are the primary indications for this medication?

This medication is used to treat multiple sclerosis (MS). Interferon is not a cure for MS, but it may help to slow disease worsening and decrease flare-ups of symptoms (such as balance problems, numbness, or weakness).

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078056912. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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 (4-4-2)
0078-0569-12
11-Digit CMS (5-4-2)
00078-0569-12

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