Subsys
NDC Package 20482-008-10

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.

Subsys is see also Warning section. Marketed by Insys Therapeutics, Inc., this product is identified by NDC 20482-008 and is authorized under FDA application NDA202788.

Identification & Billing

NDC Package Code
20482-008-10
Package Description
10 BLISTER PACK in 1 CARTON / 1 BOTTLE, SPRAY in 1 BLISTER PACK / 1 SPRAY in 1 BOTTLE, SPRAY
Product Code
20482-008
11-Digit Billing Format
20482000810
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Subsys
Dosage Form
-
Usage Information
See also Warning section. This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. 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
Insys Therapeutics, Inc.
FDA Application #
NDA202788
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-13-2012
Listing Expiration
12-31-2022
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 (20482-008). Click a package code to view its specific billing and regulatory data.

20482-008-30
30 BLISTER PACK in 1 CARTON / 1 BOTTLE, SPRAY in 1 BLISTER PACK / 1 SPRAY in 1 BOTTLE, SPRAY

* 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 20482-008-10 identifies a specific commercial package of 10 blister pack in 1 carton / 1 bottle, spray in 1 blister pack / 1 spray in 1 bottle, spray of Subsys, labeled by Insys Therapeutics, 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 Insys Therapeutics, Inc. on March 13, 2012. The current certification is valid through December 31, 2022.

What are the primary indications for this medication?

See also Warning section. This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. 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 Insys Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 20482000810. 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)
20482-008-10
11-Digit CMS (5-4-2)
20482-0008-10

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