Clonidine Hydrochloride
NDC Package 10135-708-01

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Clonidine Hydrochloride is tablets, USP are indicated in the treatment of hypertension. Marketed by Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-708 and is authorized under FDA application ANDA202297.

Identification & Billing

NDC Package Code
10135-708-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
10135-708
11-Digit Billing Format
10135070801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clonidine Hydrochloride
Dosage Form
-
Usage Information
Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets, USP may be employed alone or concomitantly with other antihypertensive agents.

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals Inc
FDA Application #
ANDA202297
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2020
Listing Expiration
12-31-2022
Exclude Flag
I
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 (10135-708). Click a package code to view its specific billing and regulatory data.

10135-708-50
500 TABLET in 1 BOTTLE

* 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 10135-708-01 identifies a specific commercial package of 100 tablet in 1 bottle of Clonidine Hydrochloride, labeled by Marlex Pharmaceuticals Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Marlex Pharmaceuticals Inc on October 01, 2020. The current certification is valid through December 31, 2022.

How is this Marlex Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135070801. 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)
10135-708-01
11-Digit CMS (5-4-2)
10135-0708-01

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