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  5. NDC Package Code: 51655-801-60 Cetirizine Hydrochloride

NDC Package 51655-801-60 Cetirizine Hydrochloride

Cetirizine Hydrochloride Tablets Tablet, Film Coated 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:
51655-801-60
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
51655-801
Proprietary Name:
Cetirizine Hydrochloride
Non-Proprietary Name:
Cetirizine Hydrochloride Tablets
Substance Name:
Cetirizine Hydrochloride
Usage Information:
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 overask a doctorchildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
11-Digit NDC Billing Format:
51655080160
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:
    Northwind Pharmaceuticals, Llc
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    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:
    ANDA078343
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-25-2023
    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
    51655-801-5230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
    51655-801-8414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 51655-801-60?

    The NDC Packaged Code 51655-801-60 is assigned to a package of 100 tablet, film coated in 1 bottle, plastic of Cetirizine Hydrochloride, a human over the counter drug labeled by Northwind Pharmaceuticals, Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 51655-801 included in the NDC Directory?

    Yes, Cetirizine Hydrochloride with product code 51655-801 is active and included in the NDC Directory. The product was first marketed by Northwind Pharmaceuticals, Llc on January 25, 2023 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 51655-801-60?

    The 11-digit format is 51655080160. 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
    5-3-251655-801-605-4-251655-0801-60