NDC Package 61037-479-04 Cetirizine Hydrochloride

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

Package Information
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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:

61037-479-04

Package Description:

240 mL in 1 BOTTLE, PLASTIC

Product Code:

61037-479

Proprietary Name:

Cetirizine Hydrochloride

Non-Proprietary Name:

Cetirizine Hydrochloride

Substance Name:

Cetirizine Hydrochloride

Usage Information:

Cetirizine hydrochloride syrup is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.

11-Digit NDC Billing Format:

61037047904

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:

Bajaj Medical, Llc

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.
Oral - Administration to or by way of the mouth.

Active Ingredient(s):

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

ANDA090191

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

09-12-2023

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

61037 - Bajaj Medical, Llc
- 61037-479 - Cetirizine Hydrochloride
  - 61037-479-04 - 240 mL in 1 BOTTLE, PLASTIC

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 Code	Package Description
61037-479-02	120 mL in 1 BOTTLE, PLASTIC
61037-479-03	480 mL in 1 BOTTLE, PLASTIC
61037-479-06	5 mL in 1 CUP, UNIT-DOSE
61037-479-12	5 mL in 1 BOX, UNIT-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61037-479-04?

The NDC Packaged Code 61037-479-04 is assigned to a package of 240 ml in 1 bottle, plastic of Cetirizine Hydrochloride, a human prescription drug labeled by Bajaj Medical, Llc. The product's dosage form is solution and is administered via oral form.

Is NDC 61037-479 included in the NDC Directory?

Yes, Cetirizine Hydrochloride with product code 61037-479 is active and included in the NDC Directory. The product was first marketed by Bajaj Medical, Llc on September 12, 2023 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 61037-479-04?

The 11-digit format is 61037047904. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	61037-479-04	5-4-2	61037-0479-04

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