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  5. NDC Package Code: 54473-166-31 Counteract Allergy

NDC Package 54473-166-31 Counteract Allergy

Loratadine 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:
54473-166-31
Package Description:
3 BOTTLE in 1 BOX / 10 TABLET in 1 BOTTLE
Product Code:
54473-166
Proprietary Name:
Counteract Allergy
Non-Proprietary Name:
Loratadine
Substance Name:
Loratadine
Usage Information:
This medication is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergies. It is also used to relieve itching from hives. Loratadine does not prevent hives or prevent/treat a serious allergic reaction (anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use loratadine in place of your epinephrine. If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions section.) If you are using the tablets or capsules, do not use in children younger than 6 years unless directed by the doctor. If you are using the liquid or chewable tablets, do not use in children younger than 2 years unless directed by the doctor.
11-Digit NDC Billing Format:
54473016631
NDC to RxNorm Crosswalk:
  • RxCUI: 311372 - loratadine 10 MG 24HR Oral Tablet
  • RxCUI: 311372 - loratadine 10 MG Oral Tablet
  • RxCUI: 311372 - loratadine 10 MG 24 HR Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Melaleuca, 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):
  • LORATADINE 10 mg/1
    • Sample Package:
    No
    FDA Application Number:
    ANDA075209
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-19-2023
    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 54473-166-31?

    The NDC Packaged Code 54473-166-31 is assigned to a package of 3 bottle in 1 box / 10 tablet in 1 bottle of Counteract Allergy, a human over the counter drug labeled by Melaleuca, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 54473-166 included in the NDC Directory?

    Yes, Counteract Allergy with product code 54473-166 is active and included in the NDC Directory. The product was first marketed by Melaleuca, Inc. on August 19, 2023 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 54473-166-31?

    The 11-digit format is 54473016631. 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
    5-3-254473-166-315-4-254473-0166-31