Potassium Chloride Solution
NDC Package 71656-021-01

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

Package Information

Potassium Chloride (potassium chloride oral) solution is a medication a mineral supplement used to treat or prevent low amounts of potassium in the blood. This formulation utilizes a solution delivery system. Marketed by Saptalis Pharmaceuticals, Llc, this product is identified by NDC 71656-021 and is authorized under FDA application ANDA211648.

Identification & Billing

NDC Package Code
71656-021-01
Package Description
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (71656-021-15)
Product Code
71656-021
11-Digit Billing Format
71656002101
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 Chloride
Non-Proprietary Name
Potassium Chloride Oral
Substance Name
Potassium Chloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
POTASSIUM CHLORIDE 1.5 g/15mL
Pharmacologic Class
Usage Information
This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with "water pills"/diuretics.

Regulatory & Marketing

Labeler Name
Saptalis Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211648
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-05-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71656-021). Click a package code to view its specific billing and regulatory data.

71656-021-02
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (71656-021-30)
71656-021-16
473 mL in 1 BOTTLE
71656-021-50
5 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (71656-021-15)
71656-021-51
5 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (71656-021-30)

* 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 71656-021-01 identifies a specific commercial package of 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 ml in 1 cup, unit-dose (71656-021-15) of Potassium Chloride, a human prescription drug labeled by Saptalis Pharmaceuticals, Llc. This solution is formulated for oral use and contains potassium chloride 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 Saptalis Pharmaceuticals, Llc on October 05, 2023. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with "water pills"/diuretics.

How is this Saptalis Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71656002101. 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)
71656-021-01
11-Digit CMS (5-4-2)
71656-0021-01

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