Nucynta
NDC Package 16590-889-72

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.

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 Stat Rx Usa Llc, this product is identified by NDC 16590-889 and is authorized under FDA application NDA022304.

Identification & Billing

NDC Package Code
16590-889-72
Package Description
120 TABLET, FILM COATED in 1 BOTTLE
Product Code
16590-889
11-Digit Billing Format
16590088972
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nucynta
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
Stat Rx Usa Llc
FDA Application #
NDA022304
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2009
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 (16590-889). Click a package code to view its specific billing and regulatory data.

16590-889-30
30 TABLET, FILM COATED in 1 BOTTLE
16590-889-60
60 TABLET, FILM COATED 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 16590-889-72 identifies a specific commercial package of 120 tablet, film coated in 1 bottle of Nucynta, labeled by Stat Rx Usa Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 120 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 Stat Rx Usa Llc on June 01, 2009. The current certification is valid through December 31, 2017.

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 Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590088972. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 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)
16590-889-72
11-Digit CMS (5-4-2)
16590-0889-72

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