Nucynta
NDC Package 55700-565-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Lake Erie Medical Dba Quality Care Products Llc, this product is identified by NDC 55700-565 and is authorized under FDA application NDA200533.

Identification & Billing

NDC Package Code
55700-565-60
Package Description
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
55700-565
11-Digit Billing Format
55700056560
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

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
Lake Erie Medical Dba Quality Care Products Llc
FDA Application #
NDA200533
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-16-2017
End Marketing Date
03-31-2021
Listing Expiration
03-31-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55700-565-60 identifies a specific commercial package of 60 tablet, film coated, extended release in 1 bottle of Nucynta ER, labeled by Lake Erie Medical Dba Quality Care Products Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 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 Lake Erie Medical Dba Quality Care Products Llc on June 16, 2017. The current certification is valid through March 31, 2021.

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 Lake Erie Medical Dba Quality Care Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55700056560. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
55700-565-60
11-Digit CMS (5-4-2)
55700-0565-60

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