Nucynta
NDC Package 50458-862-02

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 discontinued by the firm.

Nucynta is tapentadol is used to help relieve moderate to severe short-term pain (such as pain from an injury or after surgery). Marketed by Janssen Pharmaceuticals, Inc., this product is identified by NDC 50458-862 and is authorized under FDA application NDA200533.

Identification & Billing

NDC Package Code
50458-862-02
Package Description
10 BLISTER PACK in 1 BOX, UNIT-DOSE / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
50458-862
11-Digit Billing Format
50458086202

Clinical Specifications

Proprietary Name
Nucynta ER
Dosage Form
-
Usage Information
Tapentadol is used to help relieve moderate to severe short-term pain (such as pain from an injury or after surgery). It 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.

Regulatory & Marketing

Labeler Name
Janssen Pharmaceuticals, Inc.
FDA Application #
NDA200533
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-25-2011
End Marketing Date
03-31-2020
Listing Expiration
03-31-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50458-862). Click a package code to view its specific billing and regulatory data.

50458-862-01
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

* 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 50458-862-02 identifies a specific commercial package of 10 blister pack in 1 box, unit-dose / 10 tablet, film coated, extended release in 1 blister pack of Nucynta ER, labeled by Janssen 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 Janssen Pharmaceuticals, Inc. on August 25, 2011. The current certification is valid through March 31, 2020.

What are the primary indications for this medication?

Tapentadol is used to help relieve moderate to severe short-term pain (such as pain from an injury or after surgery). It 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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50458086202. 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)
50458-862-02
11-Digit CMS (5-4-2)
50458-0862-02

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