Diclofenac Epolamine System
NDC Package 83008-036-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Quality Care Products, Llc, this product is identified by NDC 83008-036 and is authorized under FDA application NDA021234.

Identification & Billing

NDC Package Code
83008-036-30
Package Description
6 POUCH in 1 CARTON / 5 SYSTEM in 1 POUCH
Product Code
83008-036
11-Digit Billing Format
83008003630
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6 EA
RxNorm Crosswalk
  • RxCUI: 855626 - diclofenac epolamine 1.3 % Twice-Daily Medicated Patch
  • RxCUI: 855626 - Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch

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
Quality Care Products, 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
08-15-2023
End Marketing Date
02-28-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83008-036-30 identifies a specific commercial package of 6 pouch in 1 carton / 5 system in 1 pouch of Diclofenac Epolamine, a human prescription drug labeled by Quality Care Products, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 6 billable units per package. 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 Quality Care Products, Llc on August 15, 2023.

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 Quality Care Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83008003630. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 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)
83008-036-30
11-Digit CMS (5-4-2)
83008-0036-30

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