Signature Care Allergy And Congestion Relief Tablet, Film Coated, Extended Release
NDC Package 21130-482-60

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

Package Information

Signature Care Allergy And Congestion Relief (loratadine, pseudoephedrine sulfate) tablets is •do not divide, crush, chew or dissolve the tabletadults and children 12 years and over1 tablet every 12 hours; not more than 2 tablets in 24 hourschildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Safeway, this product is identified by NDC 21130-482 and is authorized under FDA application ANDA076050.

Identification & Billing

NDC Package Code
21130-482-60
Package Description
20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
21130-482
11-Digit Billing Format
21130048260
RxNorm Crosswalk
  • RxCUI: 1242399 - pseudoephedrine sulfate 120 MG / loratadine 5 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1242399 - 12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet
  • RxCUI: 1242399 - loratadine 5 MG / pseudoephedrine sulfate 120 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Signature Care Allergy And Congestion Relief
Non-Proprietary Name
Loratadine, Pseudoephedrine Sulfate
Substance Name
Loratadine; Pseudoephedrine Sulfate
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
•do not divide, crush, chew or dissolve the tabletadults and children 12 years and over1 tablet every 12 hours; not more than 2 tablets in 24 hourschildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Safeway
Product Type
Human Otc Drug
FDA Application #
ANDA076050
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-02-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 21130-482-60 identifies a specific commercial package of 20 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack of Signature Care Allergy And Congestion Relief, a human over the counter drug labeled by Safeway. This tablet, film coated, extended release is formulated for oral use and contains loratadine; pseudoephedrine sulfate 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 Safeway on April 02, 2018. The current certification is valid through December 31, 2026.

How is this Safeway product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130048260. 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)
21130-482-60
11-Digit CMS (5-4-2)
21130-0482-60

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