Cetirizine Hydrochloride Tablet, Film Coated
NDC Package 70677-1007-2

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 (cetirizine hydrochloride tablets) tablets is adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. This formulation utilizes a tablet, film coated delivery system. Marketed by Strategic Sourcing Services Llc, this product is identified by NDC 70677-1007 and is authorized under FDA application ANDA078343.

Identification & Billing

NDC Package Code
70677-1007-2
Package Description
1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE
Product Code
70677-1007
11-Digit Billing Format
70677100702
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride
Non-Proprietary Name
Cetirizine Hydrochloride Tablets
Substance Name
Cetirizine Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETIRIZINE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.adults 65 years and overask a doctorchildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Strategic Sourcing Services Llc
Product Type
Human Otc Drug
FDA Application #
ANDA078343
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-12-2022
End Marketing Date
02-28-2027
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 (70677-1007). Click a package code to view its specific billing and regulatory data.

70677-1007-1
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
70677-1007-3
1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE
70677-1007-4
1 BOTTLE in 1 CARTON / 300 TABLET, FILM COATED in 1 BOTTLE

* 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 70677-1007-2 identifies a specific commercial package of 1 bottle in 1 carton / 60 tablet, film coated in 1 bottle of Cetirizine Hydrochloride, a human over the counter drug labeled by Strategic Sourcing Services Llc. This tablet, film coated 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 Strategic Sourcing Services Llc on May 12, 2022.

How is this Strategic Sourcing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70677100702. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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 (5-4-1)
70677-1007-2
11-Digit CMS (5-4-2)
70677-1007-02

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