Anticoagulant Sodium Citrate Solution
NDC Package 0338-9669-01

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

Package Information

Anticoagulant Sodium Citrate (trisodium citrate dihydrate) solution is anticoagulant Sodium Citrate 4% w/v Solution, USP is intended for use only with automated apheresis devices. This formulation utilizes a solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-9669 and is authorized under FDA application BN980123.

Identification & Billing

NDC Package Code
0338-9669-01
Package Description
250 mL in 1 BAG
Product Code
0338-9669
11-Digit Billing Format
00338966901

Clinical Specifications

Proprietary Name
Anticoagulant Sodium Citrate
Non-Proprietary Name
Trisodium Citrate Dihydrate
Substance Name
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
Extracorporeal - Administration outside of the body.
Active Ingredient(s)
TRISODIUM CITRATE DIHYDRATE 40 mg/mL
Pharmacologic Class
Usage Information
Anticoagulant Sodium Citrate 4% w/v Solution, USP is intended for use only with automated apheresis devices.

Regulatory & Marketing

Labeler Name
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
BN980123
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-02-2024
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 0338-9669-01 identifies a specific commercial package of 250 ml in 1 bag of Anticoagulant Sodium Citrate, a human prescription drug labeled by Baxter Healthcare Corporation. This solution is formulated for extracorporeal use and contains 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 Baxter Healthcare Corporation on April 02, 2024. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338966901. 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)
0338-9669-01
11-Digit CMS (5-4-2)
00338-9669-01

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