Diclofenac Epolamine System
NDC Package 85766-265-15

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

Diclofenac Epolamine systems is diclofenac patches are used to relieve pain from various conditions (e.g., sprained ankle). This formulation utilizes a system delivery system. Marketed by Sportpharm Llc, this product is identified by NDC 85766-265 and is authorized under FDA application NDA021234.

Identification & Billing

NDC Package Code
85766-265-15
Package Description
3 POUCH in 1 CARTON / 5 SYSTEM in 1 POUCH
Product Code
85766-265
11-Digit Billing Format
85766026515

Clinical Specifications

Proprietary Name
Diclofenac Epolamine
Non-Proprietary Name
Diclofenac Epolamine
Substance Name
Diclofenac Epolamine
Dosage Form
System -
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
DICLOFENAC EPOLAMINE .013 g/1
Pharmacologic Class
Usage Information
Diclofenac patches are used to relieve pain from various conditions (e.g., sprained ankle). This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

Regulatory & Marketing

Labeler Name
Sportpharm Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021234
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
11-18-2022
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 (85766-265). Click a package code to view its specific billing and regulatory data.

85766-265-30
6 POUCH in 1 CARTON / 5 SYSTEM in 1 POUCH

* 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 85766-265-15 identifies a specific commercial package of 3 pouch in 1 carton / 5 system in 1 pouch of Diclofenac Epolamine, a human prescription drug labeled by Sportpharm Llc. This system is formulated for topical use and contains diclofenac epolamine 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 Sportpharm Llc on November 18, 2022. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Diclofenac patches are used to relieve pain from various conditions (e.g., sprained ankle). This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

How is this Sportpharm Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85766026515. 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)
85766-265-15
11-Digit CMS (5-4-2)
85766-0265-15

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