Alka-seltzer
NDC Package 53666-218-14

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.

Alka-seltzer is ● fully dissolve 2 tablets in 4 ounces of water before takingadults and children12 years and over2 tablets every 4hours, or asdirected by a doctordo not exceed 8tablets in 24 hoursadults 60 yearsand over2 tablets every 4hours, or asdirected by a doctordo not exceed 4tablets in 24 hourschildren under12 yearsconsult a doctor. Marketed by Salimex, S.a., this product is identified by NDC 53666-218 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
53666-218-14
Package Description
150 BOX in 1 BOX / 6 POUCH in 1 BOX (53666-218-13) / 2 TABLET in 1 POUCH (53666-218-12)
Product Code
53666-218
11-Digit Billing Format
53666021814

Clinical Specifications

Proprietary Name
Alka-seltzer Original
Dosage Form
-
Usage Information
● fully dissolve 2 tablets in 4 ounces of water before takingadults and children12 years and over2 tablets every 4hours, or asdirected by a doctordo not exceed 8tablets in 24 hoursadults 60 yearsand over2 tablets every 4hours, or asdirected by a doctordo not exceed 4tablets in 24 hourschildren under12 yearsconsult a doctor

Regulatory & Marketing

Labeler Name
Salimex, S.a.
FDA Application #
part343
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
10-03-2017
Listing Expiration
12-31-2022
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 53666-218-14 identifies a specific commercial package of 150 box in 1 box / 6 pouch in 1 box (53666-218-13) / 2 tablet in 1 pouch (53666-218-12) of Alka-seltzer Original, labeled by Salimex, S.a.. 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 Salimex, S.a. on October 03, 2017. The current certification is valid through December 31, 2022.

How is this Salimex, S.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53666021814. 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)
53666-218-14
11-Digit CMS (5-4-2)
53666-0218-14

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