Eye Itch Relief Solution/ Drops
NDC Package 50090-7253-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Eye Itch Relief (ketotifen fumarate) solution/ dropses is a medication used to prevent and treat itching of the eyes caused by allergies (allergic/seasonal conjunctivitis). This formulation utilizes a solution/ drops delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-7253 and is authorized under FDA application NDA021996.

Identification & Billing

NDC Package Code
50090-7253-0
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code
50090-7253
11-Digit Billing Format
50090725300
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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

Clinical Specifications

Proprietary Name
Eye Itch Relief
Non-Proprietary Name
Ketotifen Fumarate
Substance Name
Ketotifen Fumarate
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
KETOTIFEN FUMARATE .25 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
Product Type
Human Otc Drug
FDA Application #
NDA021996
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50090-7253-0 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Eye Itch Relief, a human over the counter drug labeled by A-s Medication Solutions. This solution/ drops is formulated for ophthalmic use and contains ketotifen fumarate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by A-s Medication Solutions on April 01, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090725300. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
50090-7253-0
11-Digit CMS (5-4-2)
50090-7253-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.