Nucynta Tablet, Film Coated, Extended Release
NDC Package 24510-232-01

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

Nucynta (tapentadol hydrochloride) tablets is tapentadol is used to help relieve moderate to severe short-term pain (such as pain from an injury or after surgery). This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Collegium Pharmaceutical, Inc., this product is identified by NDC 24510-232 and is authorized under FDA application NDA200533.

Identification & Billing

NDC Package Code
24510-232-01
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
24510-232
11-Digit Billing Format
24510023201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nucynta ER
Non-Proprietary Name
Tapentadol Hydrochloride
Substance Name
Tapentadol Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TAPENTADOL HYDROCHLORIDE 200 mg/1
Pharmacologic Class
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.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Collegium Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA200533
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-19-2019
Listing Expiration
12-31-2027
Exclude Flag
N
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 (24510-232). Click a package code to view its specific billing and regulatory data.

24510-232-60
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 24510-232-01 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack of Nucynta ER, a human prescription drug labeled by Collegium Pharmaceutical, Inc.. This tablet, film coated, extended release is formulated for oral use and contains tapentadol hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Collegium Pharmaceutical, Inc. on April 19, 2019. The current certification is valid through December 31, 2027.

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 Collegium Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24510023201. 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)
24510-232-01
11-Digit CMS (5-4-2)
24510-0232-01

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