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  5. NDC Package Code: 65162-003-86 Cetirizine Hydrochloride

NDC Package 65162-003-86 Cetirizine Hydrochloride

Cetirizine 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:
65162-003-86
Package Description:
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code:
65162-003
Proprietary Name:
Cetirizine Hydrochloride
Non-Proprietary Name:
Cetirizine
Substance Name:
Cetirizine Hydrochloride
Usage Information:
Use only with enclosed dosing cupfind right dose on chart belowmL = milliliter adults and children 6 years and over  1 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 56 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children under 6 years of age  ask a doctor consumers with liver or kidney disease ask a doctor
11-Digit NDC Billing Format:
65162000386
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:
    Amneal Pharmaceuticals 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):
  • 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:
    ANDA090765
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-07-2009
    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 65162-003-86?

    The NDC Packaged Code 65162-003-86 is assigned to a package of 1 bottle in 1 carton / 118 ml in 1 bottle of Cetirizine Hydrochloride, a human over the counter drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is solution and is administered via oral form.

    Is NDC 65162-003 included in the NDC Directory?

    Yes, Cetirizine Hydrochloride with product code 65162-003 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on October 07, 2009 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 65162-003-86?

    The 11-digit format is 65162000386. 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
    5-3-265162-003-865-4-265162-0003-86