Leader Restorative Formula Lubricant Eye Drops Solution/ Drops
NDC Package 70000-0013-2

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

Leader Restorative Formula Lubricant Eye Drops (propylene glycol) solution/ dropses is uses• for the temporary relief of burning and irritation due to dryness of the eye. This formulation utilizes a solution/ drops delivery system. Marketed by Cardinal Health, this product is identified by NDC 70000-0013 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
70000-0013-2
Package Description
2 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER
Product Code
70000-0013
11-Digit Billing Format
70000001302
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Leader Restorative Formula Lubricant Eye Drops
Non-Proprietary Name
Propylene Glycol
Substance Name
Propylene Glycol
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)
PROPYLENE GLYCOL .6 g/100mL
Usage Information
Uses• for the temporary relief of burning and irritation due to dryness of the eye

Regulatory & Marketing

Labeler Name
Cardinal Health
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-30-2019
End Marketing Date
09-30-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70000-0013). Click a package code to view its specific billing and regulatory data.

70000-0013-1
1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER

* 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 70000-0013-2 identifies a specific commercial package of 2 bottle, dropper in 1 box / 15 ml in 1 bottle, dropper of Leader Restorative Formula Lubricant Eye Drops, a human over the counter drug labeled by Cardinal Health. This solution/ drops is formulated for ophthalmic use and contains propylene glycol 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 Cardinal Health on April 30, 2019.

How is this Cardinal Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000001302. 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)
70000-0013-2
11-Digit CMS (5-4-2)
70000-0013-02

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