Rejuvesol Solution
NDC Package 23731-7000-5

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

Package Information

Rejuvesol (sodium pyruvate, inosine, adenine, sodium phosphate, dibasic, and sodium phosphate, monobasic, monohydrate) solution is rejuvesol ® Solution is intended only for the extracorporeal rejuvenation of a RBC. This formulation utilizes a solution delivery system. Marketed by Citra Labs, Llc, this product is identified by NDC 23731-7000 and is authorized under FDA application BN950522.

Identification & Billing

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
11-Digit Billing Format
23731700005

Clinical Specifications

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
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
Extracorporeal - Administration outside of the body.
Active Ingredient(s)
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.

Regulatory & Marketing

Labeler Name
Citra Labs, Llc
Product Type
Human Prescription Drug
FDA Application #
BN950522
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-26-1997
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 23731-7000-5 identifies a specific commercial 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. This solution is formulated for extracorporeal use and contains adenine; inosine; sodium phosphate, dibasic; sodium phosphate, monobasic, monohydrate; sodium pyruvate 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 Citra Labs, Llc on February 26, 1997. The current certification is valid through December 31, 2026.

How is this Citra Labs, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 23731700005. 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 (5-4-1)
23731-7000-5
11-Digit CMS (5-4-2)
23731-7000-05

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