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  5. NDC Package Code: 16571-401-10 Cetirizine Hydrochloride

NDC Package 16571-401-10 Cetirizine Hydrochloride

Tablet 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:
16571-401-10
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
16571-401
Proprietary Name:
Cetirizine Hydrochloride
Non-Proprietary Name:
Cetirizine Hydrochloride
Substance Name:
Cetirizine Hydrochloride
Usage Information:
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 over1 tablet once a day; do not take more than 1 tablet in 24 hours.Children under 6 years of ageAsk a doctorConsumers with liver or kidney diseaseAsk a doctor
11-Digit NDC Billing Format:
16571040110
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: 1014676 - cetirizine HCl 5 MG Oral Tablet
  • RxCUI: 1014676 - cetirizine hydrochloride 5 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Rising Pharma Holdings, 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 5 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:
    ANDA077829
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-01-2009
    Listing Expiration Date:
    12-31-2025
    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 16571-401-10?

    The NDC Packaged Code 16571-401-10 is assigned to a package of 100 tablet in 1 bottle of Cetirizine Hydrochloride, a human over the counter drug labeled by Rising Pharma Holdings, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 16571-401 included in the NDC Directory?

    Yes, Cetirizine Hydrochloride with product code 16571-401 is active and included in the NDC Directory. The product was first marketed by Rising Pharma Holdings, Inc. on October 01, 2009 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 16571-401-10?

    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 16571-401-10?

    The 11-digit format is 16571040110. 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
    5-3-216571-401-105-4-216571-0401-10