Clonidine Transdermal System Usp, 0.3 Mg/day Patch
NDC Package 52817-507-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Clonidine Transdermal System Usp, 0.3 Mg/day (clonidine transdermal system) patches is a medication used alone or with other medications to treat high blood pressure (hypertension). This formulation utilizes a patch delivery system. Marketed by Trupharma, Llc, this product is identified by NDC 52817-507 and is authorized under FDA application NDA018891.

Identification & Billing

NDC Package Code
52817-507-04
Package Description
4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 1 d in 1 PATCH
Product Code
52817-507
11-Digit Billing Format
52817050704
RxNorm Crosswalk
  • RxCUI: 998671 - cloNIDine HCl 0.1 MG/Day Weekly Transdermal System
  • RxCUI: 998671 - 168 HR clonidine 0.00417 MG/HR Transdermal System
  • RxCUI: 998671 - clonidine HCl 0.1 MG/Day Weekly Transdermal System
  • RxCUI: 998671 - clonidine hydrochloride 0.1 MG/Day Weekly Transdermal Patch
  • RxCUI: 998675 - cloNIDine HCl 0.2 MG/Day Weekly Transdermal System

Clinical Specifications

Proprietary Name
Clonidine Transdermal System Usp, 0.3 Mg/day
Non-Proprietary Name
Clonidine Transdermal System
Substance Name
Clonidine
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
CLONIDINE .3 mg/d
Pharmacologic Class
Usage Information
This medication is used alone or with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Clonidine belongs to a class of drugs (central alpha agonists) that act in the brain to lower blood pressure. It works by relaxing blood vessels so blood can flow more easily.

Regulatory & Marketing

Labeler Name
Trupharma, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA018891
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
03-30-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52817-507-04 identifies a specific commercial package of 4 pouch in 1 carton / 1 patch in 1 pouch / 1 d in 1 patch of Clonidine Transdermal System Usp, 0.3 Mg/day, a human prescription drug labeled by Trupharma, Llc. This patch is formulated for transdermal use and contains clonidine 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 Trupharma, Llc on March 30, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used alone or with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Clonidine belongs to a class of drugs (central alpha agonists) that act in the brain to lower blood pressure. It works by relaxing blood vessels so blood can flow more easily.

How is this Trupharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52817050704. 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)
52817-507-04
11-Digit CMS (5-4-2)
52817-0507-04

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