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  5. NDC Package Code: 51552-1599-3 Ketotifen Fumarate

NDC Package 51552-1599-3 Ketotifen Fumarate

Powder - 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:
51552-1599-3
Package Description:
5 g in 1 CONTAINER
Product Code:
51552-1599
Non-Proprietary Name:
Ketotifen Fumarate
Substance Name:
Ketotifen Fumarate
Usage Information:
This medication is used to prevent and treat itching of the eyes caused by allergies (allergic/seasonal conjunctivitis). Ketotifen is an antihistamine for the eye that treats allergic symptoms by blocking a certain natural substance (histamine). It is also a mast cell stabilizer that prevents allergic reactions by reducing the release of natural substances that cause an allergic reaction.
11-Digit NDC Billing Format:
51552159903
Product Type:
Bulk Ingredient
Labeler Name:
Fagron Inc
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
  • KETOTIFEN FUMARATE 1 g/g
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
    Start Marketing Date:
    04-08-2021
    End Marketing Date:
    11-15-2024
    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
    51552-1599-525 g in 1 CONTAINER
    51552-1599-7100 g in 1 CONTAINER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 51552-1599-3?

    The NDC Packaged Code 51552-1599-3 is assigned to an UNFINISHED drug package of 5 g in 1 container of Ketotifen Fumarate, a bulk ingredient labeled by Fagron Inc. The product's dosage form is powder and is administered via form.

    Is NDC 51552-1599 included in the NDC Directory?

    Yes, Ketotifen Fumarate is an UNFINISHED PRODUCT with code 51552-1599 that is active and included in the NDC Directory. The product was first marketed by Fagron Inc on April 08, 2021.

    What is the 11-digit format for NDC 51552-1599-3?

    The 11-digit format is 51552159903. 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
    5-4-151552-1599-35-4-251552-1599-03