NDC Package 68516-5216-5 Albutein

Albumin (human) Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
68516-5216-5
Package Description:
1 VIAL in 1 CARTON / 20 mL in 1 VIAL (68516-5216-6)
Product Code:
Proprietary Name:
Albutein
Non-Proprietary Name:
Albumin (human)
Substance Name:
Albumin Human
Usage Information:
Hypersensitivity to albumin preparations or to any of the excipients.Severe anemia or cardiac failure with normal or increased intravascular volume.
11-Digit NDC Billing Format:
68516521605
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1741375 - albumin human 25 % in 50 ML Injection
  • RxCUI: 1741375 - 50 ML albumin human, USP 250 MG/ML Injection
  • RxCUI: 1741375 - albumin human 12.5 GM per 50 ML Injection
  • RxCUI: 1741375 - albumin human 25 % per 50 ML Injection
  • RxCUI: 1741377 - Albutein 25 % in 50 ML Injection
  • Product Type:
    Plasma Derivative
    Labeler Name:
    Grifols Usa, Llc
    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(s):
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    BLA102478
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    03-01-2022
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 68516-5216-5 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    68516521605P9046Albumin (human), 25%, 20 ml20 ML20111

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    68516-5216-05 BAG in 1 CARTON / 100 mL in 1 BAG (68516-5216-8)
    68516-5216-11 VIAL in 1 CARTON / 50 mL in 1 VIAL (68516-5216-3)
    68516-5216-21 VIAL in 1 CARTON / 100 mL in 1 VIAL (68516-5216-4)
    68516-5216-95 BAG in 1 CARTON / 50 mL in 1 BAG (68516-5216-7)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68516-5216-5?

    The NDC Packaged Code 68516-5216-5 is assigned to a package of 1 vial in 1 carton / 20 ml in 1 vial (68516-5216-6) of Albutein, a plasma derivative labeled by Grifols Usa, Llc. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 68516-5216 included in the NDC Directory?

    Yes, Albutein with product code 68516-5216 is active and included in the NDC Directory. The product was first marketed by Grifols Usa, Llc on March 01, 2022 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 NDC billing unit for package 68516-5216-5?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 68516-5216-5?

    The 11-digit format is 68516521605. 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
    5-4-168516-5216-55-4-268516-5216-05