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  5. NDC Package Code: 76385-106-17 Ketotifen Fumarate

NDC Package 76385-106-17 Ketotifen Fumarate

Solution 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:
76385-106-17
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC
Product Code:
76385-106
Proprietary Name:
Ketotifen Fumarate
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:
76385010617
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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:
    Bayshore Pharmaceuticals, Llc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    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:
    ANDA204059
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-15-2021
    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 76385-106-17?

    The NDC Packaged Code 76385-106-17 is assigned to a package of 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic of Ketotifen Fumarate, a human over the counter drug labeled by Bayshore Pharmaceuticals, Llc. The product's dosage form is solution and is administered via ophthalmic form.

    Is NDC 76385-106 included in the NDC Directory?

    Yes, Ketotifen Fumarate with product code 76385-106 is active and included in the NDC Directory. The product was first marketed by Bayshore Pharmaceuticals, Llc on October 15, 2021 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 NDC billing unit for package 76385-106-17?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 76385-106-17?

    The 11-digit format is 76385010617. 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
    5-3-276385-106-175-4-276385-0106-17