Quabic-100 Solution, Concentrate
NDC Package 81943-503-01

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

Quabic-100 (hemodialysis grade sodium bicarbonate solution) solution is use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standar ISO 13959:2014) IN A RATIO 1:1. This formulation utilizes a solution, concentrate delivery system. Marketed by Aqua Medica, S.a. De C.v., this product is identified by NDC 81943-503.

Identification & Billing

NDC Package Code
81943-503-01
Package Description
3785 mL in 1 BOTTLE
Product Code
81943-503
11-Digit Billing Format
81943050301

Clinical Specifications

Proprietary Name
Quabic-100
Non-Proprietary Name
Hemodialysis Grade Sodium Bicarbonate Solution
Substance Name
Sodium Bicarbonate
Dosage Form
Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
Administration Route
  • Hemodialysis - Administration through hemodialysate fluid.
  • Hemodialysis - Administration through hemodialysate fluid.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standar ISO 13959:2014) IN A RATIO 1:1.

Regulatory & Marketing

Labeler Name
Aqua Medica, S.a. De C.v.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
03-30-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81943-503). Click a package code to view its specific billing and regulatory data.

81943-503-02
650 mL in 1 BOTTLE
81943-503-03
500 mL 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 81943-503-01 identifies a specific commercial package of 3785 ml in 1 bottle of Quabic-100, a human over the counter drug labeled by Aqua Medica, S.a. De C.v.. This solution, concentrate is formulated for hemodialysis use and contains sodium bicarbonate 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 Aqua Medica, S.a. De C.v. on March 30, 2020. The current certification is valid through December 31, 2026.

How is this Aqua Medica, S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81943050301. 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)
81943-503-01
11-Digit CMS (5-4-2)
81943-0503-01

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