Albutein Injection, Solution
NDC Package 68516-5215-2

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

Package Information

Albutein (albumin (human)) injection is hypersensitivity to albumin preparations or to any of the excipients.Severe anemia or cardiac failure with normal or increased intravascular volume. This formulation utilizes a injection, solution delivery system. Marketed by Grifols Usa, Llc, this product is identified by NDC 68516-5215 and is authorized under FDA application BLA102478.

Identification & Billing

NDC Package Code
68516-5215-2
Package Description
1 VIAL in 1 CARTON / 100 mL in 1 VIAL (68516-5215-4)
Product Code
68516-5215
11-Digit Billing Format
68516521502
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Albutein
Non-Proprietary Name
Albumin (human)
Substance Name
Albumin Human
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Hypersensitivity to albumin preparations or to any of the excipients.Severe anemia or cardiac failure with normal or increased intravascular volume.

Regulatory & Marketing

Labeler Name
Grifols Usa, Llc
Product Type
Plasma Derivative
FDA Application #
BLA102478
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-01-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68516-5215). Click a package code to view its specific billing and regulatory data.

68516-5215-1
1 VIAL in 1 CARTON / 50 mL in 1 VIAL (68516-5215-3)
68516-5215-7
1 BAG in 1 CARTON / 50 mL in 1 BAG (68516-5215-5)
68516-5215-8
1 BAG in 1 CARTON / 100 mL in 1 BAG (68516-5215-6)

* 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 68516-5215-2 identifies a specific commercial package of 1 vial in 1 carton / 100 ml in 1 vial (68516-5215-4) of Albutein, a plasma derivative labeled by Grifols Usa, Llc. This injection, 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 March 01, 2022. 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: 68516521502. 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)
68516-5215-2
11-Digit CMS (5-4-2)
68516-5215-02

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