Mydcombi
NDC Package 81046-0111-2

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

Package Information

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

Mydcombi is (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% is indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. Marketed by Eyenovia, Inc., this product is identified by NDC 81046-0111 and is authorized under FDA application NDA215352.

Identification & Billing

NDC Package Code
81046-0111-2
Package Description
1 CARTON in 1 BOX / 1 CARTRIDGE in 1 CARTON / 1.9 mL in 1 CARTRIDGE
Product Code
81046-0111
11-Digit Billing Format
81046011102
RxNorm Crosswalk
  • RxCUI: 2638481 - phenylephrine hydrochloride 2.5 % / tropicamide 1 % Ophthalmic Spray
  • RxCUI: 2638481 - phenylephrine hydrochloride 25 MG/ML / tropicamide 10 MG/ML Ophthalmic Spray
  • RxCUI: 2638486 - Mydcombi 1 % / 2.5 % Ophthalmic Spray
  • RxCUI: 2638486 - phenylephrine hydrochloride 25 MG/ML / tropicamide 10 MG/ML Ophthalmic Spray [Mydcombi]

Clinical Specifications

Proprietary Name
Mydcombi
Dosage Form
-
Usage Information
MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% is indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired.

Regulatory & Marketing

Labeler Name
Eyenovia, Inc.
FDA Application #
NDA215352
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-09-2023
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81046-0111). Click a package code to view its specific billing and regulatory data.

81046-0111-1
1 CARTRIDGE in 1 CARTON / 1.9 mL in 1 CARTRIDGE
81046-0111-5
5 CARTON in 1 BOX / 1 CARTRIDGE in 1 CARTON / 1.9 mL in 1 CARTRIDGE

* 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 81046-0111-2 identifies a specific commercial package of 1 carton in 1 box / 1 cartridge in 1 carton / 1.9 ml in 1 cartridge of Mydcombi, labeled by Eyenovia, 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 Eyenovia, Inc. on May 09, 2023. The current certification is valid through December 31, 2024.

How is this Eyenovia, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81046011102. 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)
81046-0111-2
11-Digit CMS (5-4-2)
81046-0111-02

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