Safeway
NDC Package 21130-106-01

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

Package Information

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

Safeway is use only with enclosed dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.children 2 to under 6 years of age2.5 mL once daily. Marketed by Safeway Inc., this product is identified by NDC 21130-106 and is authorized under FDA application ANDA201546.

Identification & Billing

NDC Package Code
21130-106-01
Package Description
1 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE
Product Code
21130-106
11-Digit Billing Format
21130010601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Safeway Children Allergy Relief
Dosage Form
-
Usage Information
Use only with enclosed dosing cupfind right dose on chart belowmL = milliliteradults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.children under 2 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Safeway Inc.
FDA Application #
ANDA201546
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-20-2011
Listing Expiration
12-31-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 21130-106-01 identifies a specific commercial package of 1 bottle in 1 carton / 240 ml in 1 bottle of Safeway Children Allergy Relief, labeled by Safeway Inc.. 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 Safeway Inc. on May 20, 2011. The current certification is valid through December 31, 2019.

How is this Safeway Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130010601. 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)
21130-106-01
11-Digit CMS (5-4-2)
21130-0106-01

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