NDC Package 84826-002-01 Omlonti

Omidenepag Isopropyl Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

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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:

84826-002-01

Package Description:

1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC

Product Code:

84826-002

Proprietary Name:

Omlonti

Non-Proprietary Name:

Omidenepag Isopropyl

Substance Name:

Omidenepag Isopropyl

Usage Information:

Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

11-Digit NDC Billing Format:

84826000201

NDC to RxNorm Crosswalk:

RxCUI: 2612702 - omidenepag isopropyl 0.002 % Ophthalmic Solution
RxCUI: 2612702 - omidenepag isopropyl 0.02 MG/ML Ophthalmic Solution
RxCUI: 2612704 - OMLONTI 0.002 % Ophthalmic Solution
RxCUI: 2612704 - omidenepag isopropyl 0.02 MG/ML Ophthalmic Solution [Omlonti]
RxCUI: 2612704 - Omlonti 0.02 MG/ML Ophthalmic Solution

Product Type:

Human Prescription Drug

Labeler Name:

Ocuvex Therapeutics, 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):

OMIDENEPAG ISOPROPYL .02 mg/mL

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

NDA215092

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

09-23-2022

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

84826 - Ocuvex Therapeutics, Inc.
- 84826-002 - Omlonti
  - 84826-002-01 - 1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
84826-002-03	3 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 84826-002-01?

The NDC Packaged Code 84826-002-01 is assigned to a package of 1 bottle, plastic in 1 carton / 2.5 ml in 1 bottle, plastic of Omlonti, a human prescription drug labeled by Ocuvex Therapeutics, Inc.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Is NDC 84826-002 included in the NDC Directory?

Yes, Omlonti with product code 84826-002 is active and included in the NDC Directory. The product was first marketed by Ocuvex Therapeutics, Inc. on September 23, 2022 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 84826-002-01?

The 11-digit format is 84826000201. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	84826-002-01	5-4-2	84826-0002-01

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