Citracid-50 Solution, Concentrate
NDC Package 81943-701-01

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

Package Information

Citracid-50 (desinfectant solution for hemodialysis machine) solution is for use with 3-pump hemodialysisi machines only, using purified water (StandardUNE-EN ISO 23500-3:2019). This formulation utilizes a solution, concentrate delivery system. Marketed by Aqua Medica, S.a. De C.v., this product is identified by NDC 81943-701.

Identification & Billing

NDC Package Code
81943-701-01
Package Description
5000 mL in 1 CONTAINER
Product Code
81943-701
11-Digit Billing Format
81943070101

Clinical Specifications

Proprietary Name
Citracid-50
Non-Proprietary Name
Desinfectant Solution For Hemodialysis Machine
Substance Name
Citric Acid Monohydrate
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.
Active Ingredient(s)
CITRIC ACID MONOHYDRATE .5 g/100mL
Pharmacologic Class
Usage Information
For use with 3-pump hemodialysisi machines only, using purified water (StandardUNE-EN ISO 23500-3:2019).

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
03-30-2023
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 81943-701-01 identifies a specific commercial package of 5000 ml in 1 container of Citracid-50, 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 citric acid monohydrate 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, 2023. 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: 81943070101. 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)
81943-701-01
11-Digit CMS (5-4-2)
81943-0701-01

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