1. Home
  2. Labeler Index
  3. Terrain Pharmaceuticals
  4. 53225-1070
  5. NDC Package Code: 53225-1070-1 Diclona Gel

NDC Package 53225-1070-1 Diclona Gel

Lidocaine 4.5%,Diclofenac 1% Gel Topical - 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:
53225-1070-1
Package Description:
99 g in 1 TUBE
Product Code:
53225-1070
Proprietary Name:
Diclona Gel
Non-Proprietary Name:
Lidocaine 4.5%, Diclofenac 1%
Substance Name:
Diclofenac Sodium; Lidocaine
Usage Information:
Diclona Gel is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. Diclona Gel is contraindicated in patients with a known hypersensitivity to diclofenac sodium. Diclona Gel is contraindicated in patients in the setting of coronary artery bypass graft (CABG) surgery.
11-Digit NDC Billing Format:
53225107001
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
99 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 2600049 - diclofenac sodium 1 % / lidocaine HCl 4.5 % Topical Gel
  • RxCUI: 2600049 - diclofenac sodium 0.01 MG/MG / lidocaine hydrochloride 0.045 MG/MG Topical Gel
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Terrain Pharmaceuticals
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • DICLOFENAC SODIUM .01 g/g
  • LIDOCAINE .045 g/g
    • Pharmacologic Class(es):
  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amides - [CS]
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Decreased Prostaglandin Production - [PE] (Physiologic Effect)
  • Local Anesthesia - [PE] (Physiologic Effect)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    05-02-2022
    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 53225-1070-1?

    The NDC Packaged Code 53225-1070-1 is assigned to a package of 99 g in 1 tube of Diclona Gel, a human prescription drug labeled by Terrain Pharmaceuticals. The product's dosage form is gel and is administered via topical form.This product is billed per "GM" gram and contains an estimated amount of 99 billable units per package.

    Is NDC 53225-1070 included in the NDC Directory?

    Yes, Diclona Gel with product code 53225-1070 is active and included in the NDC Directory. The product was first marketed by Terrain Pharmaceuticals on May 02, 2022 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 53225-1070-1?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 99.

    What is the 11-digit format for NDC 53225-1070-1?

    The 11-digit format is 53225107001. 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 5-4-1 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
    5-4-153225-1070-15-4-253225-1070-01