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  5. NDC Package Code: 51991-837-16 Cetirizine Hydrochloride

NDC Package 51991-837-16 Cetirizine Hydrochloride

Solution 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:
51991-837-16
Package Description:
480 mL in 1 BOTTLE
Product Code:
51991-837
Proprietary Name:
Cetirizine Hydrochloride
Non-Proprietary Name:
Cetirizine Hydrochloride
Substance Name:
Cetirizine Hydrochloride
Usage Information:
Cetirizine hydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.
11-Digit NDC Billing Format:
51991083716
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
480 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1014673 - cetirizine HCl 5 MG in 5 mL Oral Solution
  • RxCUI: 1014673 - cetirizine hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 1014673 - cetirizine HCl 1 MG/ML Oral Syrup
  • RxCUI: 1014673 - cetirizine HCl 5 MG per 5 ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Breckenridge Pharmaceutical, 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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CETIRIZINE HYDROCHLORIDE 1 mg/mL
    • 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:
    ANDA078488
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-03-2013
    End Marketing Date:
    11-30-2024
    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
    51991-837-04120 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 51991-837-16?

    The NDC Packaged Code 51991-837-16 is assigned to a package of 480 ml in 1 bottle of Cetirizine Hydrochloride, a human prescription drug labeled by Breckenridge Pharmaceutical, Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 51991-837 included in the NDC Directory?

    Yes, Cetirizine Hydrochloride with product code 51991-837 is active and included in the NDC Directory. The product was first marketed by Breckenridge Pharmaceutical, Inc. on December 03, 2013.

    What is the NDC billing unit for package 51991-837-16?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 480.

    What is the 11-digit format for NDC 51991-837-16?

    The 11-digit format is 51991083716. 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
    5-3-251991-837-165-4-251991-0837-16