Fentanyl
NDC Package 68258-3040-1

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 inactivated by the FDA.

Fentanyl is a medication used to help relieve severe ongoing pain (such as due to cancer). Marketed by Dispensing Solutions, Inc., this product is identified by NDC 68258-3040 and is authorized under FDA application NDA019813.

Identification & Billing

NDC Package Code
68258-3040-1
Package Description
5 POUCH in 1 BOX / 1 PATCH in 1 POUCH
Product Code
68258-3040
11-Digit Billing Format
68258304001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fentanyl
Dosage Form
-
Usage Information
This medication is used to help relieve severe ongoing pain (such as due to cancer). Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the patch form of fentanyl to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

Regulatory & Marketing

Labeler Name
Dispensing Solutions, Inc.
FDA Application #
NDA019813
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2004
Listing Expiration
12-31-2017
Exclude Flag
I
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 68258-3040-1 identifies a specific commercial package of 5 pouch in 1 box / 1 patch in 1 pouch of Fentanyl, labeled by Dispensing Solutions, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 5 billable units per package. 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 Dispensing Solutions, Inc. on October 01, 2004. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to help relieve severe ongoing pain (such as due to cancer). Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the patch form of fentanyl to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

How is this Dispensing Solutions, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68258304001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 total billable units per package. 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 (5-4-1)
68258-3040-1
11-Digit CMS (5-4-2)
68258-3040-01

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