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  5. NDC Package Code: 47335-343-88 Cetirizine Hydrochloride

NDC Package 47335-343-88 Cetirizine Hydrochloride

Tablet, Chewable 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:
47335-343-88
Package Description:
100 TABLET, CHEWABLE in 1 BOTTLE
Product Code:
47335-343
Proprietary Name:
Cetirizine Hydrochloride
Non-Proprietary Name:
Cetirizine Hydrochloride
Substance Name:
Cetirizine Hydrochloride
Usage Information:
May be taken with or without waterFor 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 overask a doctorchildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
11-Digit NDC Billing Format:
47335034388
NDC to RxNorm Crosswalk:
  • RxCUI: 1014643 - cetirizine HCl 5 MG Chewable Tablet
  • RxCUI: 1014643 - cetirizine hydrochloride 5 MG Chewable Tablet
  • RxCUI: 1014674 - cetirizine HCl 10 MG Chewable Tablet
  • RxCUI: 1014674 - cetirizine hydrochloride 10 MG Chewable Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    Dosage Form:
    Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CETIRIZINE HYDROCHLORIDE 5 mg/1
  • CETIRIZINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA090142
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-09-2011
    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
    47335-343-1530 TABLET, CHEWABLE in 1 BOTTLE
    47335-343-16100 TABLET, CHEWABLE in 1 BOTTLE
    47335-343-8330 TABLET, CHEWABLE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 47335-343-88?

    The NDC Packaged Code 47335-343-88 is assigned to a package of 100 tablet, chewable in 1 bottle of Cetirizine Hydrochloride, a human over the counter drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, chewable and is administered via oral form.

    Is NDC 47335-343 included in the NDC Directory?

    Yes, Cetirizine Hydrochloride with product code 47335-343 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on September 09, 2011 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 47335-343-88?

    The 11-digit format is 47335034388. 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
    5-3-247335-343-885-4-247335-0343-88