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  5. NDC Package Code: 0591-3510-04 Clonidine Transdermal System

NDC Package 0591-3510-04 Clonidine Transdermal System

Clonidine Patch Transdermal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0591-3510-04
Package Description:
4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0591-3510-54) / 7 d in 1 PATCH
Product Code:
0591-3510
Proprietary Name:
Clonidine Transdermal System
Non-Proprietary Name:
Clonidine
Substance Name:
Clonidine
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.
11-Digit NDC Billing Format:
00591351004
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Actavis Pharma, Inc.
    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(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • CLONIDINE .3 mg/d
    • Pharmacologic Class(es):
  • Adrenergic alpha2-Agonists - [MoA] (Mechanism of Action)
  • Central alpha-2 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA090873
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-06-2014
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0591-3510-04?

    The NDC Packaged Code 0591-3510-04 is assigned to a package of 4 pouch in 1 carton / 1 patch in 1 pouch (0591-3510-54) / 7 d in 1 patch of Clonidine Transdermal System, a human prescription drug labeled by Actavis Pharma, Inc.. The product's dosage form is patch and is administered via transdermal form.

    Is NDC 0591-3510 included in the NDC Directory?

    Yes, Clonidine Transdermal System with product code 0591-3510 is active and included in the NDC Directory. The product was first marketed by Actavis Pharma, Inc. on May 06, 2014 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0591-3510-04?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0591-3510-04?

    The 11-digit format is 00591351004. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20591-3510-045-4-200591-3510-04