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  5. NDC Package Code: 68001-436-97 Cetirizine Hydrochloride (allergy)

NDC Package 68001-436-97 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:
68001-436-97
Package Description:
1 BOTTLE in 1 CARTON / 300 TABLET in 1 BOTTLE
Product Code:
68001-436
Proprietary Name:
Cetirizine Hydrochloride (allergy)
Non-Proprietary Name:
Cetirizine Hydrochloride
Substance Name:
Cetirizine Hydrochloride
Usage Information:
For 10 mg:adults and children 6 years and over one 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 doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
11-Digit NDC Billing Format:
68001043697
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
Product Type:
Human Otc Drug
Labeler Name:
Bluepoint Laboratories
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:
    06-19-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    68001-436-041 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE
    68001-436-1610 TABLET in 1 BLISTER PACK
    68001-436-961 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68001-436-97?

    The NDC Packaged Code 68001-436-97 is assigned to a package of 1 bottle in 1 carton / 300 tablet in 1 bottle of Cetirizine Hydrochloride (allergy), a human over the counter drug labeled by Bluepoint Laboratories. The product's dosage form is tablet and is administered via oral form.

    Is NDC 68001-436 included in the NDC Directory?

    Yes, Cetirizine Hydrochloride (allergy) with product code 68001-436 is active and included in the NDC Directory. The product was first marketed by Bluepoint Laboratories on June 19, 2020 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 68001-436-97?

    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 1.

    What is the 11-digit format for NDC 68001-436-97?

    The 11-digit format is 68001043697. 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
    5-3-268001-436-975-4-268001-0436-97