Acuvue Theravision With Ketotifen
NDC Package 60123-019-30

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Acuvue Theravision With Ketotifen is aCUVUE® Theravision™ with Ketotifen is a daily wear, daily disposable etafilcon A drug-eluting contact lens for prevention ocular itch due to allergic conjunctivitis and correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eye(s), are suitable for contact lens wear and do not have more than 1 D of astigmatism.The lens contains an H1 histamine receptor antagonist for the prevention of ocular itch due to allergic conjunctivitis. Marketed by Johnson & Johnson Vision Care, Inc., this product is identified by NDC 60123-019 and is authorized under FDA application NDA022388.

Identification & Billing

NDC Package Code
60123-019-30
Package Description
30 BLISTER PACK in 1 CARTON / 1 DRUG-ELUTING CONTACT LENS in 1 BLISTER PACK
Product Code
60123-019
11-Digit Billing Format
60123001930
RxNorm Crosswalk
  • RxCUI: 2604045 - ketotifen 19 MG Drug-Eluting Contact Lens
  • RxCUI: 2604045 - ketotifen 0.019 MG Drug-Eluting Contact Lens
  • RxCUI: 2604045 - ketotifen 19 MG (as ketotifen fumarate 43 MCG) Drug-Eluting Contact Lens
  • RxCUI: 2604049 - ACUVUE Theravision 19 MCG Drug-Eluting Contact Lens
  • RxCUI: 2604049 - ketotifen 0.019 MG Drug-Eluting Contact Lens [Acuvue Theravision]

Clinical Specifications

Proprietary Name
Acuvue Theravision With Ketotifen
Dosage Form
-
Usage Information
ACUVUE® Theravision™ with Ketotifen is a daily wear, daily disposable etafilcon A drug-eluting contact lens for prevention ocular itch due to allergic conjunctivitis and correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eye(s), are suitable for contact lens wear and do not have more than 1 D of astigmatism.The lens contains an H1 histamine receptor antagonist for the prevention of ocular itch due to allergic conjunctivitis. The prevention of itch has been demonstrated to last through 12 hours in clinical trials; however, the lens may be worn for longer than 12 hours in a single day.

Regulatory & Marketing

Labeler Name
Johnson & Johnson Vision Care, Inc.
FDA Application #
NDA022388
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-28-2022
Listing Expiration
12-31-2023
Exclude Flag
I
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 60123-019-30 identifies a specific commercial package of 30 blister pack in 1 carton / 1 drug-eluting contact lens in 1 blister pack of Acuvue Theravision With Ketotifen, labeled by Johnson & Johnson Vision Care, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Johnson & Johnson Vision Care, Inc. on February 28, 2022. The current certification is valid through December 31, 2023.

How is this Johnson & Johnson Vision Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60123001930. 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 (5-3-2)
60123-019-30
11-Digit CMS (5-4-2)
60123-0019-30

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