Intersol Solution
NDC Package 0942-9601-12

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

Package Information

Intersol (platelet additive 3) solution is rx only For use with the AMICUS Separator only.Store at Controlled Room Temperature. This formulation utilizes a solution delivery system. Marketed by Fenwal, Inc., this product is identified by NDC 0942-9601 and is authorized under FDA application BN080041.

Identification & Billing

NDC Package Code
0942-9601-12
Package Description
500 mL in 1 BAG
Product Code
0942-9601
11-Digit Billing Format
00942960112

Clinical Specifications

Proprietary Name
Intersol
Non-Proprietary Name
Platelet Additive 3
Substance Name
Sodium Acetate; Sodium Chloride; Sodium Phosphate, Dibasic, Unspecified Form; 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
Rx only For use with the AMICUS Separator only.Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Definition of "Controlled Room Temperature": "A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15°C and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours ... The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non isothermal effects of storage temperature variations." Reference: United States Pharmacopeia, General Notices. United States Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway, Rockville, MD. Dispose of waste in appropriate biohazard container or according to local regulatory requirements.Indications and Usage: InterSol solution is an isotonic solution designed to replace a proportion of the plasma used in the storage of AMICUS™-derived leukoreduced apheresis platelets under standard blood banking conditions. There is no direct therapeutic effect to be expected from the formulation. The solution should never be infused directly into a patient.InterSol platelets are leukocyte-reduced apheresis platelet concentrates that are stored in a mix of 65% InterSol and 35% plasma, nominal. InterSol platelets prepared within the range of Table 1 may be stored for up to 5 days at 20-24°C, with continuous agitation.

Regulatory & Marketing

Labeler Name
Fenwal, Inc.
Product Type
Human Prescription Drug
FDA Application #
BN080041
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-25-2012
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0942-9601-12 identifies a specific commercial package of 500 ml in 1 bag of Intersol, a human prescription drug labeled by Fenwal, Inc.. This solution is formulated for intravenous use and contains sodium acetate; sodium chloride; sodium phosphate, dibasic, unspecified form; 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 Fenwal, Inc. on October 25, 2012. The current certification is valid through December 31, 2026.

How is this Fenwal, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00942960112. 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)
0942-9601-12
11-Digit CMS (5-4-2)
00942-9601-12

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