Plasmanate Solution
NDC Package 13533-613-25

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

Package Information

Plasmanate (plasma protein fraction (human)) solution is treatment of Shock — Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. This formulation utilizes a solution delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 13533-613 and is authorized under FDA application BLA101140.

Identification & Billing

NDC Package Code
13533-613-25
Package Description
1 VIAL in 1 CARTON / 250 mL in 1 VIAL (13533-613-26)
Product Code
13533-613
11-Digit Billing Format
13533061325
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1729443 - plasma protein fraction 12.5 GM in 250 ML (5 % ) Injection
  • RxCUI: 1729443 - 250 ML plasma protein fraction 50 MG/ML Injection
  • RxCUI: 1729443 - plasma protein fraction 12.5 GM per 250 ML Injection
  • RxCUI: 1729444 - Plasmanate 12.5 GM in 250 ML (5 % ) Injection
  • RxCUI: 1729444 - 250 ML plasma protein fraction 50 MG/ML Injection [Plasmanate]

Clinical Specifications

Proprietary Name
Plasmanate
Non-Proprietary Name
Plasma Protein Fraction (human)
Substance Name
Albumin Human
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ALBUMIN HUMAN 2.5 g/50mL
Pharmacologic Class
Usage Information
Treatment of Shock — Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage.(3,4) Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss.In infants and small children, Plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection.

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
Product Type
Plasma Derivative
FDA Application #
BLA101140
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-02-1958
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 13533-613-25 identifies a specific commercial package of 1 vial in 1 carton / 250 ml in 1 vial (13533-613-26) of Plasmanate, a plasma derivative labeled by Grifols Usa, Llc. This solution is formulated for intravenous use and contains albumin human 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 Grifols Usa, Llc on October 02, 1958. The current certification is valid through December 31, 2026.

How is this Grifols Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13533061325. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
13533-613-25
11-Digit CMS (5-4-2)
13533-0613-25

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