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  5. NDC Package Code: 43598-735-35 Levocetirizine Dihydrochloride

NDC Package 43598-735-35 Levocetirizine Dihydrochloride

Tablet, Coated Oral - 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:
43598-735-35
Package Description:
1 BOTTLE in 1 CARTON / 35 TABLET, COATED in 1 BOTTLE
Product Code:
43598-735
Proprietary Name:
Levocetirizine Dihydrochloride
Non-Proprietary Name:
Levocetirizine Dihydrochloride
Substance Name:
Levocetirizine Dihydrochloride
Usage Information:
Levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. It is also used to relieve itching and hives. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Levocetirizine does not prevent hives or prevent/treat a serious allergic reaction (such as anaphylaxis). If your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use levocetirizine in place of your epinephrine.
11-Digit NDC Billing Format:
43598073535
Product Type:
Human Otc Drug
Labeler Name:
Dr. Reddy's Laboratories Inc.
Dosage Form:
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1
  • LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA210375
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-12-2018
    Listing Expiration Date:
    12-31-2025
    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
    43598-735-041 BOTTLE in 1 CARTON / 120 TABLET, COATED in 1 BOTTLE
    43598-735-221 BOTTLE in 1 CARTON / 55 TABLET, COATED in 1 BOTTLE
    43598-735-792 BLISTER PACK in 1 CARTON / 5 TABLET, COATED in 1 BLISTER PACK
    43598-735-801 BOTTLE in 1 CARTON / 80 TABLET, COATED in 1 BOTTLE
    43598-735-952 BOTTLE in 1 CARTON / 200 TABLET, COATED in 1 BOTTLE
    43598-735-9710000 TABLET, COATED in 1 POUCH

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43598-735-35?

    The NDC Packaged Code 43598-735-35 is assigned to a package of 1 bottle in 1 carton / 35 tablet, coated in 1 bottle of Levocetirizine Dihydrochloride, a human over the counter drug labeled by Dr. Reddy's Laboratories Inc.. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 43598-735 included in the NDC Directory?

    Yes, Levocetirizine Dihydrochloride with product code 43598-735 is active and included in the NDC Directory. The product was first marketed by Dr. Reddy's Laboratories Inc. on March 12, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 43598-735-35?

    The 11-digit format is 43598073535. 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
    5-3-243598-735-355-4-243598-0735-35