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  5. NDC Package Code: 0942-9601-12 Intersol

NDC Package 0942-9601-12 Intersol

Platelet Additive 3 Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0942-9601-12
Package Description:
500 mL in 1 BAG
Product Code:
0942-9601
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
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.
11-Digit NDC Billing Format:
00942960112
Product Type:
Human Prescription Drug
Labeler Name:
Fenwal, Inc.
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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • SODIUM ACETATE 442 mg/100mL
  • SODIUM CHLORIDE 452 mg/100mL
  • SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 305 mg/100mL
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 93 mg/100mL
  • TRISODIUM CITRATE DIHYDRATE 318 mg/100mL
    • Pharmacologic Class(es):
  • Acidifying Activity - [MoA] (Mechanism of Action)
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Calcium Chelating Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    BN080041
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-25-2012
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0942-9601-12?

    The NDC Packaged Code 0942-9601-12 is assigned to a package of 500 ml in 1 bag of Intersol, a human prescription drug labeled by Fenwal, Inc.. The product's dosage form is solution and is administered via intravenous form.

    Is NDC 0942-9601 included in the NDC Directory?

    Yes, Intersol with product code 0942-9601 is active and included in the NDC Directory. The product was first marketed by Fenwal, Inc. on October 25, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0942-9601-12?

    The 11-digit format is 00942960112. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20942-9601-125-4-200942-9601-12