Clonidine Hydrochloride Tablet, Extended Release
NDC Package 70069-044-01

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

Package Information

Clonidine Hydrochloride tablets is clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)]. This formulation utilizes a tablet, extended release delivery system. Marketed by Somerset Therapeutics, Llc, this product is identified by NDC 70069-044 and is authorized under FDA application ANDA211433.

Identification & Billing

NDC Package Code
70069-044-01
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
70069-044
11-Digit Billing Format
70069004401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 1013930 - cloNIDine HCl 0.1 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1013930 - 12 HR clonidine hydrochloride 0.1 MG Extended Release Oral Tablet
  • RxCUI: 1013930 - clonidine hydrochloride 0.1 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Clonidine Hydrochloride
Non-Proprietary Name
Clonidine Hydrochloride
Substance Name
Clonidine Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLONIDINE HYDROCHLORIDE .1 mg/1
Pharmacologic Class
Usage Information
Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Somerset Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211433
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-04-2025
Listing Expiration
12-31-2026
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 70069-044-01 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Clonidine Hydrochloride, a human prescription drug labeled by Somerset Therapeutics, Llc. This tablet, extended release is formulated for oral use and contains clonidine 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 Somerset Therapeutics, Llc on March 04, 2025. The current certification is valid through December 31, 2026.

How is this Somerset Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70069004401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
70069-044-01
11-Digit CMS (5-4-2)
70069-0044-01

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