Sumavel Dosepro
NDC Package 63481-367-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Sumavel Dosepro is a . Marketed by Endo Pharmaceuticals, Inc., this product is identified by NDC 63481-367 and is authorized under FDA application NDA022239.

Identification & Billing

NDC Package Code
63481-367-01
Package Description
1 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS
Product Code
63481-367
11-Digit Billing Format
63481036701

Clinical Specifications

Proprietary Name
Sumavel Dosepro
Dosage Form
-

Regulatory & Marketing

Labeler Name
Endo Pharmaceuticals, Inc.
FDA Application #
NDA022239
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-08-2015
End Marketing Date
04-30-2019
Listing Expiration
04-30-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63481-367). Click a package code to view its specific billing and regulatory data.

63481-367-06
6 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS
63481-367-51
1 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS
63481-367-54
4 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS

* 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 63481-367-01 identifies a specific commercial package of 1 syringe, glass in 1 carton / .5 ml in 1 syringe, glass of Sumavel Dosepro, labeled by Endo Pharmaceuticals, 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 Endo Pharmaceuticals, Inc. on June 08, 2015. The current certification is valid through April 30, 2019.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63481036701. 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)
63481-367-01
11-Digit CMS (5-4-2)
63481-0367-01

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