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  5. NDC Package Code: 68016-023-43 Childrens Cetirizine Hydrochloride

NDC Package 68016-023-43 Childrens Cetirizine Hydrochloride

Cetirizine Hydrochloride Solution Oral - 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:
68016-023-43
Package Description:
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
Product Code:
68016-023
Proprietary Name:
Childrens Cetirizine Hydrochloride
Non-Proprietary Name:
Cetirizine Hydrochloride
Substance Name:
Cetirizine Hydrochloride
Usage Information:
Use only with enclosed dosing cupadults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.adults 65 years and older1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.children 2 to under 6 years of age1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.children under 2 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
11-Digit NDC Billing Format:
68016002343
NDC to RxNorm Crosswalk:
  • RxCUI: 1014673 - cetirizine HCl 5 MG in 5 mL Oral Solution
  • RxCUI: 1014673 - cetirizine hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 1014673 - cetirizine HCl 1 MG/ML Oral Syrup
  • RxCUI: 1014673 - cetirizine HCl 5 MG per 5 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Chain Drug Consortium, Llc (premier Value)
    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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CETIRIZINE HYDROCHLORIDE 5 mg/5mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA090182
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-22-2008
    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 68016-023-43?

    The NDC Packaged Code 68016-023-43 is assigned to a package of 1 bottle in 1 carton / 120 ml in 1 bottle of Childrens Cetirizine Hydrochloride, a human over the counter drug labeled by Chain Drug Consortium, Llc (premier Value). The product's dosage form is solution and is administered via oral form.

    Is NDC 68016-023 included in the NDC Directory?

    Yes, Childrens Cetirizine Hydrochloride with product code 68016-023 is active and included in the NDC Directory. The product was first marketed by Chain Drug Consortium, Llc (premier Value) on April 22, 2008 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 68016-023-43?

    The 11-digit format is 68016002343. 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
    5-3-268016-023-435-4-268016-0023-43