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  5. NDC Package Code: 36800-975-01 Topcare Maximum Redness Relief Eye Drops

NDC Package 36800-975-01 Topcare Maximum Redness Relief Eye Drops

Glycerin,Naphazoline Hydrochloride Solution Ophthalmic - 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:
36800-975-01
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER
Product Code:
36800-975
Proprietary Name:
Topcare Maximum Redness Relief Eye Drops
Non-Proprietary Name:
Glycerin, Naphazoline Hydrochloride
Substance Name:
Glycerin; Naphazoline Hydrochloride
Usage Information:
UsesFor the relief of redness of the eye due to minor eye irritationsFor the temporary relief of burning and irritation due to dryness of the eyeFor use as a protectant against further irritation or dryness of the eye
11-Digit NDC Billing Format:
36800097501
NDC to RxNorm Crosswalk:
  • RxCUI: 1235200 - glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic Solution
  • RxCUI: 1235200 - glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic Solution
  • RxCUI: 1235200 - glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Topco Assoc Llc
    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):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • GLYCERIN .5 g/100mL
  • NAPHAZOLINE HYDROCHLORIDE .03 g/100mL
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Glycerol - [CS]
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Non-Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M018
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    02-04-2020
    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 36800-975-01?

    The NDC Packaged Code 36800-975-01 is assigned to a package of 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper of Topcare Maximum Redness Relief Eye Drops, a human over the counter drug labeled by Topco Assoc Llc. The product's dosage form is solution and is administered via ophthalmic form.

    Is NDC 36800-975 included in the NDC Directory?

    Yes, Topcare Maximum Redness Relief Eye Drops with product code 36800-975 is active and included in the NDC Directory. The product was first marketed by Topco Assoc Llc on February 04, 2020 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 36800-975-01?

    The 11-digit format is 36800097501. 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 5-3-2 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
    5-3-236800-975-015-4-236800-0975-01