Fentanyl Buccal
NDC Package 0591-3575-96

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.

Fentanyl Buccal is a . Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-3575 and is authorized under FDA application ANDA079075.

Identification & Billing

NDC Package Code
0591-3575-96
Package Description
7 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK (0591-3575-04)
Product Code
0591-3575
11-Digit Billing Format
00591357596

Clinical Specifications

Proprietary Name
Fentanyl Buccal
Dosage Form
-

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
FDA Application #
ANDA079075
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2013
End Marketing Date
01-01-2013
Listing Expiration
01-01-2013
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 0591-3575-96 identifies a specific commercial package of 7 blister pack in 1 carton / 4 tablet in 1 blister pack (0591-3575-04) of Fentanyl Buccal, labeled by Actavis Pharma, 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 Actavis Pharma, Inc. on January 01, 2013. The current certification is valid through January 01, 2013.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591357596. 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)
0591-3575-96
11-Digit CMS (5-4-2)
00591-3575-96

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