NDC Package 50458-862-01 Nucynta ER

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

50458-862-01

Package Description:

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Product Code:

50458-862

Proprietary Name:

Nucynta ER

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.

11-Digit NDC Billing Format:

50458086201

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

60 EA

Labeler Name:

Janssen Pharmaceuticals, Inc.

Sample Package:

FDA Application Number:

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 Date:

03-31-2020

Exclude Flag:

Code Structure:

50458 - Janssen Pharmaceuticals, Inc.
- 50458-862 - Nucynta
  - 50458-862-01 - 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
50458-862-02	10 BLISTER PACK in 1 BOX, UNIT-DOSE / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 50458-862-01?

The NDC Packaged Code 50458-862-01 is assigned to a package of 60 tablet, film coated, extended release in 1 bottle of Nucynta ER, labeled by Janssen Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 50458-862 included in the NDC Directory?

No, Nucynta ER with product code 50458-862 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Janssen Pharmaceuticals, Inc. on August 25, 2011 and its listing in the NDC Directory is set to expire on March 31, 2020 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 50458-862-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

What is the 11-digit format for NDC 50458-862-01?

The 11-digit format is 50458086201. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	50458-862-01	5-4-2	50458-0862-01

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