Flexbumin Injection, Solution
NDC Package 0944-0495-05

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

Package Information

Flexbumin (albumin human) injection is fLEXBUMIN 5% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia and cardiopulmonary bypass surgery. This formulation utilizes a injection, solution delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 0944-0495 and is authorized under FDA application BLA101452.

Identification & Billing

NDC Package Code
0944-0495-05
Package Description
2 BAG in 1 CARTON / 250 mL in 1 BAG (0944-0495-06)
Product Code
0944-0495
11-Digit Billing Format
00944049505
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Flexbumin
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.
Active Ingredient(s)
ALBUMIN HUMAN .05 g/mL
Pharmacologic Class
Usage Information
FLEXBUMIN 5% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia and cardiopulmonary bypass surgery.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Plasma Derivative
FDA Application #
BLA101452
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-31-2014
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 0944-0495-05 identifies a specific commercial package of 2 bag in 1 carton / 250 ml in 1 bag (0944-0495-06) of Flexbumin, a plasma derivative labeled by Takeda Pharmaceuticals America, Inc.. 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 Takeda Pharmaceuticals America, Inc. on July 31, 2014. The current certification is valid through December 31, 2026.

How is this Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00944049505. 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 (4-4-2)
0944-0495-05
11-Digit CMS (5-4-2)
00944-0495-05

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