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  5. NDC Package Code: 0362-3971-05 Dyclopro

NDC Package 0362-3971-05 Dyclopro

Dyclonine Hydrochloride Solution 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:
0362-3971-05
Package Description:
1 BOTTLE in 1 BOTTLE / 30 mL in 1 BOTTLE
Product Code:
0362-3971
Proprietary Name:
Dyclopro
Non-Proprietary Name:
Dyclonine Hydrochloride
Substance Name:
Dyclonine Hydrochloride
Usage Information:
Dyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures.Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions.
11-Digit NDC Billing Format:
00362397105
NDC to RxNorm Crosswalk:
  • RxCUI: 1048281 - dyclonine HCl 0.5 % Mucous Membrane Topical Solution
  • RxCUI: 1048281 - dyclonine hydrochloride 5 MG/ML Mucous Membrane Topical Solution
  • RxCUI: 1048281 - dyclonine hydrochloride 0.5 % Mucous Membrane Topical Solution
  • RxCUI: 2199132 - DycloPro 0.5 % Mucous Membrane Topical Solution
  • RxCUI: 2199132 - dyclonine hydrochloride 5 MG/ML Mucous Membrane Topical Solution [Dyclopro]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Septodont Inc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    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):
  • DYCLONINE HYDROCHLORIDE 5 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    ANDA200480
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-01-2019
    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 0362-3971-05?

    The NDC Packaged Code 0362-3971-05 is assigned to a package of 1 bottle in 1 bottle / 30 ml in 1 bottle of Dyclopro, a human prescription drug labeled by Septodont Inc. The product's dosage form is solution and is administered via topical form.

    Is NDC 0362-3971 included in the NDC Directory?

    Yes, Dyclopro with product code 0362-3971 is active and included in the NDC Directory. The product was first marketed by Septodont Inc on September 01, 2019 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 11-digit format for NDC 0362-3971-05?

    The 11-digit format is 00362397105. 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
    4-4-20362-3971-055-4-200362-3971-05