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  5. NDC Package Code: 62938-0004-3 Loratadine

NDC Package 62938-0004-3 Loratadine

Tablet, Orally Disintegrating - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
62938-0004-3
Package Description:
3024 BLISTER PACK in 1 BOX / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code:
62938-0004
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:
62938000403
Product Type:
Drug For Further Processing
Labeler Name:
Catalent Uk Swindon Zydis Ltd
Dosage Form:
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Active Ingredient(s):
  • LORATADINE 5 mg/1
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    12-12-2006
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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
    62938-0004-13024 BLISTER PACK in 1 BOX / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
    62938-0004-23024 BLISTER PACK in 1 BOX / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 62938-0004-3?

    The NDC Packaged Code 62938-0004-3 is assigned to an UNFINISHED drug package of 3024 blister pack in 1 box / 10 tablet, orally disintegrating in 1 blister pack of Loratadine, drug for further processing labeled by Catalent Uk Swindon Zydis Ltd. The product's dosage form is tablet, orally disintegrating and is administered via form.

    Is NDC 62938-0004 included in the NDC Directory?

    Yes, Loratadine is an UNFINISHED PRODUCT with code 62938-0004 that is active and included in the NDC Directory. The product was first marketed by Catalent Uk Swindon Zydis Ltd on December 12, 2006 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 62938-0004-3?

    The 11-digit format is 62938000403. 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 5-4-1 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
    5-4-162938-0004-35-4-262938-0004-03