Additive Formula 3 Solution
NDC Package 14537-832-03

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

Package Information

Additive Formula 3 (dextrose monohydrate, trisodium citrate dihydrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate, and adenine) solution is use only with Trima Accel red blood cell (RBC) apheresis collections. This formulation utilizes a solution delivery system. Marketed by Terumo Bct, Ltd, this product is identified by NDC 14537-832 and is authorized under FDA application BN001214.

Identification & Billing

NDC Package Code
14537-832-03
Package Description
6 POUCH in 1 CASE / 6 BAG in 1 POUCH (14537-832-01) / 100 mL in 1 BAG (14537-832-00)
Product Code
14537-832
11-Digit Billing Format
14537083203

Clinical Specifications

Proprietary Name
Additive Formula 3
Non-Proprietary Name
Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine
Substance Name
Adenine; Citric Acid Monohydrate; Dextrose Monohydrate; Sodium Chloride; Sodium Phosphate, Monobasic, Monohydrate; Trisodium Citrate Dihydrate
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)
Pharmacologic Class
Usage Information
Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).]

Regulatory & Marketing

Labeler Name
Terumo Bct, Ltd
Product Type
Human Prescription Drug
FDA Application #
BN001214
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-29-2002
Listing Expiration
12-31-2027
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 14537-832-03 identifies a specific commercial package of 6 pouch in 1 case / 6 bag in 1 pouch (14537-832-01) / 100 ml in 1 bag (14537-832-00) of Additive Formula 3, a human prescription drug labeled by Terumo Bct, Ltd. This solution is formulated for intravenous use and contains adenine; citric acid monohydrate; dextrose monohydrate; sodium chloride; sodium phosphate, monobasic, monohydrate; trisodium citrate dihydrate 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 Terumo Bct, Ltd on May 29, 2002. The current certification is valid through December 31, 2027.

How is this Terumo Bct, Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14537083203. 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)
14537-832-03
11-Digit CMS (5-4-2)
14537-0832-03

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