1. Home
  2. Labeler Index
  3. Armas Pharmaceuticals Inc.
  4. 72485-617
  5. NDC Package Code: 72485-617-10 Ketotifen Fumarate Ophthalmic Solution

NDC Package 72485-617-10 Ketotifen Fumarate Ophthalmic Solution

Ketotifen Fumarate Solution/ Drops Ophthalmic - 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:
72485-617-10
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code:
72485-617
Proprietary Name:
Ketotifen Fumarate Ophthalmic Solution
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:
72485061710
NDC to RxNorm Crosswalk:
  • RxCUI: 311237 - ketotifen 0.025 % Ophthalmic Solution
  • RxCUI: 311237 - ketotifen 0.25 MG/ML Ophthalmic Solution
  • RxCUI: 311237 - ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution
  • RxCUI: 311237 - ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Armas Pharmaceuticals Inc.
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • KETOTIFEN FUMARATE .25 mg/mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077958
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-09-2023
    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 72485-617-10?

    The NDC Packaged Code 72485-617-10 is assigned to a package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Ketotifen Fumarate Ophthalmic Solution, a human over the counter drug labeled by Armas Pharmaceuticals Inc.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 72485-617 included in the NDC Directory?

    Yes, Ketotifen Fumarate Ophthalmic Solution with product code 72485-617 is active and included in the NDC Directory. The product was first marketed by Armas Pharmaceuticals Inc. on October 09, 2023 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 72485-617-10?

    The 11-digit format is 72485061710. 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
    5-3-272485-617-105-4-272485-0617-10