Xtampza Capsule, Extended Release
NDC Package 24510-110-10

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

Xtampza (oxycodone) capsules is a medication used to help relieve severe ongoing pain (such as due to cancer). This formulation utilizes a capsule, extended release delivery system. Marketed by Collegium Pharmaceutical, Inc., this product is identified by NDC 24510-110 and is authorized under FDA application NDA208090.

Identification & Billing

NDC Package Code
24510-110-10
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
24510-110
11-Digit Billing Format
24510011010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1790527 - oxyCODONE 9 MG 12HR Extended Release Oral Capsule, Abuse-Deterrent
  • RxCUI: 1790527 - Abuse-Deterrent 12 HR oxycodone 9 MG Extended Release Oral Capsule
  • RxCUI: 1790527 - oxycodone 9 MG (equivalent to 10 MG oxycodone HCl) 12 HR Extended Release Oral Capsule 12 HR Extended Release Oral Capsule, Abuse-Deterrent
  • RxCUI: 1790527 - oxycodone 9 MG 12 HR Extended Release Oral Capsule, Abuse-Deterrent
  • RxCUI: 1790533 - Xtampza ER 9 MG 12HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Xtampza ER
Non-Proprietary Name
Oxycodone
Substance Name
Oxycodone
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXYCODONE 9 mg/1
Pharmacologic Class
Usage Information
This medication is used to help relieve severe ongoing pain (such as due to cancer). Oxycodone 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. Higher doses of this drug (more than 36 milligrams per dose or 72 milligrams per day) should be used only if you have been regularly taking moderate to large amounts of an opioid medication. These doses may cause overdose (even death) if taken by a person who has not been regularly taking opioids. Do not use the extended-release form of oxycodone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Collegium Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208090
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-10-2016
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 (24510-110). Click a package code to view its specific billing and regulatory data.

24510-110-20
20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

* 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 24510-110-10 identifies a specific commercial package of 100 capsule, extended release in 1 bottle, plastic of Xtampza ER, a human prescription drug labeled by Collegium Pharmaceutical, Inc.. This capsule, extended release is formulated for oral use and contains oxycodone 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 May 10, 2016. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to help relieve severe ongoing pain (such as due to cancer). Oxycodone 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. Higher doses of this drug (more than 36 milligrams per dose or 72 milligrams per day) should be used only if you have been regularly taking moderate to large amounts of an opioid medication. These doses may cause overdose (even death) if taken by a person who has not been regularly taking opioids. Do not use the extended-release form of oxycodone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

How is this Collegium Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24510011010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
24510-110-10
11-Digit CMS (5-4-2)
24510-0110-10

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