NDC Package 0121-0874-04 Cetirizine Hydrochloride

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

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:
0121-0874-04
Package Description:
120 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Cetirizine Hydrochloride
Non-Proprietary Name:
Cetirizine Hydrochloride
Substance Name:
Cetirizine Hydrochloride
Usage Information:
Perennial Allergic RhinitisCetirizine hydrochloride is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age.  Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.Chronic UrticariaCetirizine hydrochloride is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age.  It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.
11-Digit NDC Billing Format:
00121087404
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
120 ML
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Pai Holdings, Llc Dba Pai Pharma
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.
Sample Package:
No
FDA Application Number:
ANDA078412
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
02-12-2024
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.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0121-0874-16480 mL in 1 BOTTLE

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Frequently Asked Questions

What is NDC 0121-0874-04?

The NDC Packaged Code 0121-0874-04 is assigned to a package of 120 ml in 1 bottle of Cetirizine Hydrochloride, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. The product's dosage form is solution and is administered via oral form.

Is NDC 0121-0874 included in the NDC Directory?

Yes, Cetirizine Hydrochloride with product code 0121-0874 is active and included in the NDC Directory. The product was first marketed by Pai Holdings, Llc Dba Pai Pharma on February 12, 2024 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 NDC billing unit for package 0121-0874-04?

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 120.

What is the 11-digit format for NDC 0121-0874-04?

The 11-digit format is 00121087404. 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 4-4-2 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
4-4-20121-0874-045-4-200121-0874-04