Digifab
NDC Package 0281-0365-10

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.

Digifab is a . Marketed by Savage Laboratories A Division Of Fougera Pharmaceuticals Inc., this product is identified by NDC 0281-0365 and is authorized under FDA application BLA103910.

Identification & Billing

NDC Package Code
0281-0365-10
Package Description
1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON
Product Code
0281-0365
11-Digit Billing Format
00281036510

Clinical Specifications

Proprietary Name
Digifab
Dosage Form
-

Regulatory & Marketing

Labeler Name
Savage Laboratories A Division Of Fougera Pharmaceuticals Inc.
FDA Application #
BLA103910
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-31-2001
End Marketing Date
08-31-2014
Listing Expiration
08-31-2014
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 0281-0365-10 identifies a specific commercial package of 1 injection, powder, lyophilized, for solution in 1 carton of Digifab, labeled by Savage Laboratories A Division Of Fougera 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 Savage Laboratories A Division Of Fougera Pharmaceuticals Inc. on August 31, 2001. The current certification is valid through August 31, 2014.

How is this Savage Laboratories A Division Of Fougera Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00281036510. 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)
0281-0365-10
11-Digit CMS (5-4-2)
00281-0365-10

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