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  4. NDC Product Code: 80425-0330 Diclona Patch

NDC 80425-0330 Diclona Patch

Lidocaine,Diclofenac Patch Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 80425-0330?
  4. Diclona Patch 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:
80425-0330
Proprietary Name:
Diclona Patch
Non-Proprietary Name: [1]
Lidocaine, Diclofenac
Substance Name: [2]
Diclofenac Sodium; Lidocaine Hydrochloride
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]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Advanced Rx Pharmacy Of Tennessee, Llc
    Labeler Code:
    80425
    Product Label ID:
    fa3ecbbb-86e7-6fca-e053-6394a90a56d9
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    04-26-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 80425-0330?

    The NDC code 80425-0330 is assigned by the FDA to the product Diclona Patch which is a human prescription drug product labeled by Advanced Rx Pharmacy Of Tennessee, Llc. The generic name of Diclona Patch is lidocaine, diclofenac. The product's dosage form is patch and is administered via topical form. The product is distributed in a single package with assigned NDC code 80425-0330-1 5 pouch in 1 box / 3 patch in 1 pouch / 1 g 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 Diclona Patch?

    Diclona Patch is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.

    What are Diclona Patch 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.
    • DICLOFENAC SODIUM .0125 g/g - A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
    • LIDOCAINE HYDROCHLORIDE .045 g/g - A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.

    Which are Diclona Patch UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Diclona Patch?

    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: 2632946 - diclofenac sodium 1.25 % / lidocaine hydrochloride 4.5 % Medicated Patch
    • RxCUI: 2632946 - diclofenac sodium 0.0125 MG/MG / lidocaine hydrochloride 0.045 MG/MG Medicated Patch

    Which are the Pharmacologic Classes for Diclona Patch?

    * Please review the disclaimer below.

    Patient Education

    Gabapentin


    Gabapentin capsules, tablets, and oral solution are used along with other medications to help control certain types of seizures in people who have epilepsy. Gabapentin capsules, tablets, and oral solution are also used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Gabapentin extended-release tablets (Horizant) are used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Gabapentin is in a class of medications called anticonvulsants. Gabapentin treats seizures by decreasing abnormal excitement in the brain. Gabapentin relieves the pain of PHN by changing the way the body senses pain. It is not known exactly how gabapentin works to treat restless legs syndrome.
    [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.

    [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".