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  5. NDC Package Code: 68788-8204-0 Cetirizine Hydrochloride (allergy)

NDC Package 68788-8204-0 Cetirizine Hydrochloride (allergy)

Cetirizine Hydrochloride Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
68788-8204-0
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
68788-8204
Proprietary Name:
Cetirizine Hydrochloride (allergy)
Non-Proprietary Name:
Cetirizine Hydrochloride
Substance Name:
Cetirizine Hydrochloride
Usage Information:
For 5 mg:adults and children 6 years and over1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hourschildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctorFor 10 mg:adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.  A 5 mg product may be appropriate for less severe symptoms.adults 65 years and over ask a doctorchildren under 6 years of age ask a doctorconsumers with liver or kidney diseaseask a doctor
11-Digit NDC Billing Format:
68788820400
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1014678 - cetirizine HCl 10 MG Oral Tablet
  • RxCUI: 1014678 - cetirizine hydrochloride 10 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Preferred Pharmaceuticals Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CETIRIZINE HYDROCHLORIDE 10 mg/1
    • 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:
    ANDA090760
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-01-2022
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    68788-8204-114 TABLET in 1 BOTTLE
    68788-8204-330 TABLET in 1 BOTTLE
    68788-8204-515 TABLET in 1 BOTTLE
    68788-8204-660 TABLET in 1 BOTTLE
    68788-8204-990 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68788-8204-0?

    The NDC Packaged Code 68788-8204-0 is assigned to a package of 100 tablet in 1 bottle of Cetirizine Hydrochloride (allergy), a human over the counter drug labeled by Preferred Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package.

    Is NDC 68788-8204 included in the NDC Directory?

    Yes, Cetirizine Hydrochloride (allergy) with product code 68788-8204 is active and included in the NDC Directory. The product was first marketed by Preferred Pharmaceuticals Inc. on April 01, 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 68788-8204-0?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 68788-8204-0?

    The 11-digit format is 68788820400. 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
    5-4-168788-8204-05-4-268788-8204-00