Sodium Acetate Injection, Solution, Concentrate
NDC Package 71357-002-10

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

Package Information

Sodium Acetate injection is a human prescription drug administered via intravenous route. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Milla Pharmaceuticals Inc., this product is identified by NDC 71357-002 and is authorized under FDA application ANDA214805.

Identification & Billing

NDC Package Code
71357-002-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CASE / 20 mL in 1 VIAL, SINGLE-DOSE (71357-002-01)
Product Code
71357-002
11-Digit Billing Format
71357000210
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sodium Acetate
Non-Proprietary Name
Sodium Acetate
Substance Name
Sodium Acetate
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
SODIUM ACETATE 164 mg/mL

Regulatory & Marketing

Labeler Name
Milla Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214805
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-17-2025
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 71357-002-10 identifies a specific commercial package of 10 vial, single-dose in 1 case / 20 ml in 1 vial, single-dose (71357-002-01) of Sodium Acetate, a human prescription drug labeled by Milla Pharmaceuticals Inc.. This injection, solution, concentrate is formulated for intravenous use and contains sodium acetate 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 Milla Pharmaceuticals Inc. on January 17, 2025. The current certification is valid through December 31, 2026.

How is this Milla Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71357000210. 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 (5-3-2)
71357-002-10
11-Digit CMS (5-4-2)
71357-0002-10

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