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  5. NDC Package Code: 70000-0716-1 Leader Olopatadine Hydrochloride

NDC Package 70000-0716-1 Leader Olopatadine Hydrochloride

Olopatadine Hydrochloride Solution Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
70000-0716-1
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 3.5 mL in 1 BOTTLE, PLASTIC
Product Code:
70000-0716
Proprietary Name:
Leader Olopatadine Hydrochloride
Non-Proprietary Name:
Olopatadine Hydrochloride
Substance Name:
Olopatadine Hydrochloride
Usage Information:
Adults and children 2 years of age and older:put 1 drop in the affected eye(s) once daily, no more than once per dayif using other ophthalmic products while using this product, wait at least 5 minutes between each productreplace cap after each usechildren under 2 years of age:consult a doctor
11-Digit NDC Billing Format:
70000071601
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Cardinal Health
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
Ophthalmic - Administration to the external eye.
Active Ingredient(s):
OLOPATADINE HYDROCHLORIDE 2 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA206087
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
04-15-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

Frequently Asked Questions

What is NDC 70000-0716-1?

The NDC Packaged Code 70000-0716-1 is assigned to a package of 1 bottle, plastic in 1 carton / 3.5 ml in 1 bottle, plastic of Leader Olopatadine Hydrochloride, a human over the counter drug labeled by Cardinal Health. The product's dosage form is solution and is administered via ophthalmic form.

Is NDC 70000-0716 included in the NDC Directory?

Yes, Leader Olopatadine Hydrochloride with product code 70000-0716 is active and included in the NDC Directory. The product was first marketed by Cardinal Health on April 15, 2025 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 70000-0716-1?

The 11-digit format is 70000071601. 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 5-4-1 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-170000-0716-15-4-270000-0716-01