Abstral
NDC Package 42747-221-32

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 inactivated by the FDA.

Abstral is a medication used to help relieve sudden (breakthrough) pain in people who are already taking opioid medication around-the-clock for cancer pain. Marketed by Prostrakan, Inc., this product is identified by NDC 42747-221 and is authorized under FDA application NDA022510.

Identification & Billing

NDC Package Code
42747-221-32
Package Description
32 TABLET in 1 BLISTER PACK
Product Code
42747-221
11-Digit Billing Format
42747022132
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
32 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Abstral
Dosage Form
-
Usage Information
This medication is used to help relieve sudden (breakthrough) pain in people who are already taking opioid medication around-the-clock for cancer pain. 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. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

Regulatory & Marketing

Labeler Name
Prostrakan, Inc.
FDA Application #
NDA022510
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-07-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42747-221). Click a package code to view its specific billing and regulatory data.

42747-221-12
12 TABLET in 1 BLISTER PACK

* 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 42747-221-32 identifies a specific commercial package of 32 tablet in 1 blister pack of Abstral, labeled by Prostrakan, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 32 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 Prostrakan, Inc. on January 07, 2011. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to help relieve sudden (breakthrough) pain in people who are already taking opioid medication around-the-clock for cancer pain. 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. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42747022132. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 32 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 (5-3-2)
42747-221-32
11-Digit CMS (5-4-2)
42747-0221-32

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