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  5. NDC Package Code: 23731-7000-5 Rejuvesol

NDC Package 23731-7000-5 Rejuvesol

Sodium Pyruvate,Inosine,Adenine,Sodium Phosphate,Dibasic,And Sodium - 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:
23731-7000-5
Package Description:
12 VIAL, SINGLE-USE in 1 CASE / 50 mL in 1 VIAL, SINGLE-USE
Product Code:
23731-7000
Proprietary Name:
Rejuvesol
Non-Proprietary Name:
Sodium Pyruvate, Inosine, Adenine, Sodium Phosphate, Dibasic, And Sodium Phosphate, Monobasic, Monohydrate
Substance Name:
Adenine; Inosine; Sodium Phosphate, Dibasic; Sodium Phosphate, Monobasic, Monohydrate; Sodium Pyruvate
Usage Information:
Rejuvesol ® Solution is intended only for the extracorporeal rejuvenation of a RBC. It should never be directly administered to Humans. Rejuvesol ® Solution must not be added to whole blood because the additional plasma may reduce the effectiveness of the rejuvenation process. Immediately after rejuvenation, RBC must either be washed via an approved protocol prior to transfusion or glycerolized and frozen. RBC which have been rejuvenated, glycerolized, and frozen must be deglycerolized via an approved protocol prior to transfusion. RBC rejuvenated before 6 days of storage may achieve 2,3-DPG levels in excess of 2 times normal and ATP levels in excess of 1.5 times normal. 5,6 In patients with reduced arterial blood p0 2 of less than 40 torr, the use of RBC rejuvenated before 6 days of storage are contraindicated because their high 2,3-DPG levels and low oxygen affinity may impair proper oxygenation of the red blood cells in the lung. 7Rejuvenated RBC are further processed prior to transfusion to remove the un-used portion of rejuvesol ® Solution, by-products of the rejuvenation process, and any other potential storage-related impurities in rejuvesol ® Solution. Based on the concentration of the residual inosine in rejuvenated RBC that are either washed or deglycerolized, the average washout of inosine was calculated to be > 97.4%. A literature search for potential toxicity associated with the ingredients that comprise rejuvesol ® Solution, including potential metabolites, was conducted. 23 This report concludes that no theoretical contraindications would be associated with the transfusion of a single unit of unwashed, rejuvenated RBC that would contain amounts of pyruvate, inosine, adenine, phosphate, hypoxanthine, uric acid, and lactate that exceed reference values (excluding lactate) as these substances are naturally metabolized and/or are excreted. 23The maximum number of properly processed rejuvenated RBC that can be transfused to a single recipient over their entire lifetime has not been determined.
11-Digit NDC Billing Format:
23731700005
Product Type:
Human Prescription Drug
Labeler Name:
Citra Labs, Llc
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
  • Extracorporeal - Administration outside of the body.
    • Active Ingredient(s):
  • ADENINE .034 g/50mL
  • INOSINE 1.34 g/50mL
  • SODIUM PHOSPHATE, DIBASIC .73 g/50mL
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .311 g/50mL
  • SODIUM PYRUVATE .55 g/50mL
    • Sample Package:
    No
    FDA Application Number:
    BN950522
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-26-1997
    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 23731-7000-5?

    The NDC Packaged Code 23731-7000-5 is assigned to a package of 12 vial, single-use in 1 case / 50 ml in 1 vial, single-use of Rejuvesol, a human prescription drug labeled by Citra Labs, Llc. The product's dosage form is solution and is administered via extracorporeal form.

    Is NDC 23731-7000 included in the NDC Directory?

    Yes, Rejuvesol with product code 23731-7000 is active and included in the NDC Directory. The product was first marketed by Citra Labs, Llc on February 26, 1997 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 23731-7000-5?

    The 11-digit format is 23731700005. 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 5-4-1 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
    5-4-123731-7000-55-4-223731-7000-05