Cetirizine Hydrochloride Solution
NDC Package 61037-479-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Cetirizine Hydrochloride solution is cetirizine hydrochloride syrup is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine. This formulation utilizes a solution delivery system. Marketed by Bajaj Medical, Llc, this product is identified by NDC 61037-479 and is authorized under FDA application ANDA090191.

Identification & Billing

NDC Package Code
61037-479-06
Package Description
5 mL in 1 CUP, UNIT-DOSE
Product Code
61037-479
11-Digit Billing Format
61037047906
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
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
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Cetirizine hydrochloride syrup is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.

Regulatory & Marketing

Labeler Name
Bajaj Medical, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090191
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-12-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61037-479). Click a package code to view its specific billing and regulatory data.

61037-479-02
120 mL in 1 BOTTLE, PLASTIC
61037-479-03
480 mL in 1 BOTTLE, PLASTIC
61037-479-04
240 mL in 1 BOTTLE, PLASTIC
61037-479-12
5 mL in 1 BOX, UNIT-DOSE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61037-479-06 identifies a specific commercial package of 5 ml in 1 cup, unit-dose of Cetirizine Hydrochloride, a human prescription drug labeled by Bajaj Medical, Llc. This solution is formulated for oral use and contains cetirizine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bajaj Medical, Llc on September 12, 2023. The current certification is valid through December 31, 2026.

How is this Bajaj Medical, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61037047906. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
61037-479-06
11-Digit CMS (5-4-2)
61037-0479-06

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.