Signature Care Cough Relief Suspension, Extended Release
NDC Package 21130-520-21

11-digit billing NDC: 21130052021
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Signature Care Cough Relief (dextromethorphan polistirex) suspension is •shake bottle well before use•measure only with dosing cup provided•do not use dosing cup with other products•dose as follows or as directed by a doctoradults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hourschildren 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hourschildren 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hourschildren under 4 years of agedo not use. This formulation utilizes a suspension, extended release delivery system. Marketed by Safeway, this product is identified by NDC 21130-520 and is authorized under FDA application ANDA091135.

Identification & Billing

NDC Package Code
21130-520-21
Package Description
1 BOTTLE in 1 CARTON / 89 mL in 1 BOTTLE
Product Code
21130-520
11-Digit Billing Format
21130052021
RxNorm Crosswalk
  • RxCUI: 1373045 - dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension
  • RxCUI: 1373045 - 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension

Clinical Specifications

Proprietary Name
Signature Care Cough Relief
Non-Proprietary Name
Dextromethorphan Polistirex
Substance Name
Dextromethorphan Hydrobromide
Dosage Form
Suspension, Extended Release - A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL
Pharmacologic Class
Usage Information
•shake bottle well before use•measure only with dosing cup provided•do not use dosing cup with other products•dose as follows or as directed by a doctoradults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hourschildren 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hourschildren 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hourschildren under 4 years of agedo not use

Regulatory & Marketing

Labeler Name
Safeway
Product Type
Human Otc Drug
FDA Application #
ANDA091135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-08-2021
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 21130-520-21 identifies a specific commercial package of 1 bottle in 1 carton / 89 ml in 1 bottle of Signature Care Cough Relief, a human over the counter drug labeled by Safeway. This suspension, extended release is formulated for oral use and contains dextromethorphan hydrobromide 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 July 08, 2021. The current certification is valid through December 31, 2027.

How is this Safeway product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130052021. 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)
21130-520-21
11-Digit CMS (5-4-2)
21130-0520-21

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