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  5. NDC Package Code: 55681-302-03 Cetirizine Hydrochloride 10 Mg

NDC Package 55681-302-03 Cetirizine Hydrochloride 10 Mg

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:
55681-302-03
Package Description:
300 TABLET in 1 BOTTLE
Product Code:
55681-302
Proprietary Name:
Cetirizine Hydrochloride 10 Mg
Non-Proprietary Name:
Cetirizine Hydrochloride
Substance Name:
Cetirizine Hydrochloride
Usage Information:
Adults and children 6 years of age and overOne 10 mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms.adults 65 years and older ask a doctorchildren under 6 years of age ask a doctorconsumers with liver or kidney diseaseask a doctor
11-Digit NDC Billing Format:
55681030203
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:
    Twin Med, Llc
    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:
    ANDA209274
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-02-2022
    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 55681-302-03?

    The NDC Packaged Code 55681-302-03 is assigned to a package of 300 tablet in 1 bottle of Cetirizine Hydrochloride 10 Mg, a human over the counter drug labeled by Twin Med, Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 55681-302 included in the NDC Directory?

    Yes, Cetirizine Hydrochloride 10 Mg with product code 55681-302 is active and included in the NDC Directory. The product was first marketed by Twin Med, Llc on March 02, 2022 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 11-digit format for NDC 55681-302-03?

    The 11-digit format is 55681030203. 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
    5-3-255681-302-035-4-255681-0302-03