Cetirizine Hydrochloride
NDC Package 64679-693-01

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cetirizine Hydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine. Marketed by Wockhardt Llc., this product is identified by NDC 64679-693 and is authorized under FDA application ANDA078757.

Identification & Billing

NDC Package Code
64679-693-01
Package Description
1 BOTTLE, GLASS in 1 CARTON / 120 mL in 1 BOTTLE, GLASS
Product Code
64679-693
11-Digit Billing Format
64679069301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride
Dosage Form
-
Usage Information
Cetirizine hydrochloride is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.

Regulatory & Marketing

Labeler Name
Wockhardt Llc.
FDA Application #
ANDA078757
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-28-2009
Listing Expiration
12-31-2017
Exclude Flag
I
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 (64679-693). Click a package code to view its specific billing and regulatory data.

64679-693-02
480 mL in 1 BOTTLE, GLASS
64679-693-03
480 mL in 1 BOTTLE, PLASTIC

* 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 64679-693-01 identifies a specific commercial package of 1 bottle, glass in 1 carton / 120 ml in 1 bottle, glass of Cetirizine Hydrochloride, labeled by Wockhardt Llc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Wockhardt Llc. on August 28, 2009. The current certification is valid through December 31, 2017.

How is this Wockhardt Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64679069301. 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)
64679-693-01
11-Digit CMS (5-4-2)
64679-0693-01

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