Potassium Acetate Injection, Solution, Concentrate
NDC Package 65219-512-50

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

Package Information

Potassium Acetate injection is (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 65219-512 and is authorized under FDA application ANDA217515.

Identification & Billing

NDC Package Code
65219-512-50
Package Description
25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (65219-512-02)
Product Code
65219-512
11-Digit Billing Format
65219051250
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Potassium Acetate
Non-Proprietary Name
Potassium Acetate
Substance Name
Potassium 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)
POTASSIUM ACETATE 196 mg/mL
Pharmacologic Class
Usage Information
Potassium Acetate Injection (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA217515
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-27-2024
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 65219-512-50 identifies a specific commercial package of 25 vial, pharmacy bulk package in 1 tray / 50 ml in 1 vial, pharmacy bulk package (65219-512-02) of Potassium Acetate, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution, concentrate is formulated for intravenous use and contains potassium 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 Fresenius Kabi Usa, Llc on November 27, 2024. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65219051250. 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)
65219-512-50
11-Digit CMS (5-4-2)
65219-0512-50

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