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  5. NDC Package Code: 43598-764-25 Olopatadine Hydrochloride Ophthalmic Solution

NDC Package 43598-764-25 Olopatadine Hydrochloride Ophthalmic Solution

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
43598-764-25
Package Description:
2 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC
Product Code:
43598-764
Proprietary Name:
Olopatadine Hydrochloride Ophthalmic Solution
Non-Proprietary Name:
Olopatadine Hydrochloride Ophthalmic
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 use   children under 2 years of age: consult a doctor
11-Digit NDC Billing Format:
43598076425
NDC to RxNorm Crosswalk:
  • RxCUI: 1111343 - olopatadine HCl 0.2 % Ophthalmic Solution
  • RxCUI: 1111343 - olopatadine 2 MG/ML Ophthalmic Solution
  • RxCUI: 1111343 - olopatadine 0.2 % Ophthalmic Solution
  • RxCUI: 1111343 - olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Dr. Reddy's Laboratories Inc.
    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
  • OLOPATADINE HYDROCHLORIDE 2 mg/mL
    • Pharmacologic Class(es):
  • Decreased Histamine Release - [PE] (Physiologic Effect)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Histamine-1 Receptor Inhibitor - [EPC] (Established Pharmacologic Class)
  • Mast Cell Stabilizer - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA209752
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-01-2020
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    43598-764-021 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC
    43598-764-101000 BOTTLE, PLASTIC in 1 CASE / 2.5 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43598-764-25?

    The NDC Packaged Code 43598-764-25 is assigned to a package of 2 bottle, plastic in 1 carton / 2.5 ml in 1 bottle, plastic of Olopatadine Hydrochloride Ophthalmic Solution, a human over the counter drug labeled by Dr. Reddy's Laboratories Inc.. The product's dosage form is solution and is administered via ophthalmic form.

    Is NDC 43598-764 included in the NDC Directory?

    Yes, Olopatadine Hydrochloride Ophthalmic Solution with product code 43598-764 is active and included in the NDC Directory. The product was first marketed by Dr. Reddy's Laboratories Inc. on September 01, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 43598-764-25?

    The 11-digit format is 43598076425. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-243598-764-255-4-243598-0764-25