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  4. NDC Product Code: 0591-3508 Clonidine Transdermal System

NDC 0591-3508 Clonidine Transdermal System

Clonidine Patch Transdermal - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0591-3508?
  4. Clonidine Transdermal System Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes
  9. Patient Education

Product Information

NDC Product Code:
0591-3508
Proprietary Name:
Clonidine Transdermal System
Non-Proprietary Name: [1]
Clonidine
Substance Name: [2]
Clonidine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Labeler Name: [5]
    Actavis Pharma, Inc.
    Labeler Code:
    0591
    Product Label ID:
    99a59495-2a48-4276-bbe3-cdd55a45aba4
    FDA Application Number: [6]
    ANDA090873
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    05-06-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0591-3508-04

    Package Description: 4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0591-3508-54) / 7 d in 1 PATCH

    Price per Unit: $6.31792 per EA

    Product Details

    What is NDC 0591-3508?

    The NDC code 0591-3508 is assigned by the FDA to the product Clonidine Transdermal System which is a human prescription drug product labeled by Actavis Pharma, Inc.. The generic name of Clonidine Transdermal System is clonidine. The product's dosage form is patch and is administered via transdermal form. The product is distributed in a single package with assigned NDC code 0591-3508-04 4 pouch in 1 carton / 1 patch in 1 pouch (0591-3508-54) / 7 d in 1 patch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Clonidine Transdermal System?

    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.

    What are Clonidine Transdermal System Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • CLONIDINE .1 mg/d - An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.

    Which are Clonidine Transdermal System UNII Codes?

    The UNII codes for the active ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Clonidine Transdermal System?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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

    Which are the Pharmacologic Classes for Clonidine Transdermal System?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Clonidine Transdermal Patch


    Transdermal clonidine is used alone or in combination with other medications to treat high blood pressure. Clonidine is in a class of medications called centrally acting alpha-agonist hypotensive agents. It works by decreasing your heart rate and relaxing the blood vessels so that blood can flow more easily through the body.
    [Learn More]


    Blood Pressure Medicines


    What is high blood pressure?

    High blood pressure, also called hypertension, is when blood puts too much pressure against the walls of your arteries. About 1 in 3 adults have high blood pressure, usually with no symptoms. But it can cause serious problems such as stroke, heart failure, heart attack, and kidney disease.

    What lifestyle changes can help lower high blood pressure?

    Healthy lifestyle changes can help reduce high blood pressure:

    What if lifestyle changes alone cannot lower blood pressure?

    Sometimes lifestyle changes alone cannot control or lower your high blood pressure. In that case, your health care provider may prescribe blood pressure medicines.

    How do blood pressure medicines work?

    Blood pressure medicines work in different ways to lower blood pressure:

    • Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) keep your blood vessels from narrowing as much
    • Calcium channel blockers prevent calcium from entering the muscle cells of your heart and blood vessels. This allows the blood vessels to relax.
    • Diuretics remove extra water and sodium (salt) from your body. This lowers the amount of fluid in your blood. Diuretics are often used with other high blood pressure medicines, sometimes in one combined pill.
    • Beta blockers help your heart beat slower and with less force. This means that your heart pumps less blood through your blood vessels. Beta blockers are typically used only as a backup option or if you also have certain other conditions.

    Often, two or more medicines work better than one. While taking the medicines, it is still important to keep up with your healthy lifestyle changes.

    NIH: National Heart, Lung, and Blood Institute


    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".