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  5. NDC Package Code: 81943-701-01 Citracid-50

NDC Package 81943-701-01 Citracid-50

Desinfectant Solution For Hemodialysis Machine Solution, Concentrate Hemodialysis - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
81943-701-01
Package Description:
5000 mL in 1 CONTAINER
Product Code:
81943-701
Proprietary Name:
Citracid-50
Non-Proprietary Name:
Desinfectant Solution For Hemodialysis Machine
Substance Name:
Citric Acid Monohydrate
Usage Information:
For use with 3-pump hemodialysisi machines only, using purified water (StandardUNE-EN ISO 23500-3:2019).
11-Digit NDC Billing Format:
81943070101
Product Type:
Human Otc Drug
Labeler Name:
Aqua Medica, S.a. De C.v.
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(s):
  • Hemodialysis - Administration through hemodialysate fluid.
    • Active Ingredient(s):
  • CITRIC ACID MONOHYDRATE .5 g/100mL
    • Pharmacologic Class(es):
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    part356
    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:
    03-30-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 81943-701-01?

    The NDC Packaged Code 81943-701-01 is assigned to a 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.. The product's dosage form is solution, concentrate and is administered via hemodialysis form.

    Is NDC 81943-701 included in the NDC Directory?

    Yes, Citracid-50 with product code 81943-701 is active and included in the NDC Directory. The product was first marketed by Aqua Medica, S.a. De C.v. on March 30, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 81943-701-01?

    The 11-digit format is 81943070101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-281943-701-015-4-281943-0701-01