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  5. NDC Package Code: 0781-5284-64 Cetirizine Hydrochloride

NDC Package 0781-5284-64 Cetirizine Hydrochloride

Tablet, Chewable 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:
0781-5284-64
Package Description:
30 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5284-06)
Product Code:
0781-5284
Proprietary Name:
Cetirizine Hydrochloride
Non-Proprietary Name:
Cetirizine Hydrochloride
Substance Name:
Cetirizine Hydrochloride
Usage Information:
•may be taken with or without wateradults 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 age ask a doctor consumers with liver or kidney disease ask a doctor
11-Digit NDC Billing Format:
00781528464
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1014674 - cetirizine HCl 10 MG Chewable Tablet
  • RxCUI: 1014674 - cetirizine hydrochloride 10 MG Chewable Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Sandoz 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.
    • 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:
    ANDA078692
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-14-2008
    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 0781-5284-64?

    The NDC Packaged Code 0781-5284-64 is assigned to a package of 30 blister pack in 1 carton / 1 tablet, chewable in 1 blister pack (0781-5284-06) of Cetirizine Hydrochloride, a human over the counter drug labeled by Sandoz Inc. The product's dosage form is tablet, chewable and is administered via oral form.

    Is NDC 0781-5284 included in the NDC Directory?

    Yes, Cetirizine Hydrochloride with product code 0781-5284 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on February 14, 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 NDC billing unit for package 0781-5284-64?

    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 30.

    What is the 11-digit format for NDC 0781-5284-64?

    The 11-digit format is 00781528464. 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 4-4-2 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
    4-4-20781-5284-645-4-200781-5284-64