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  5. NDC Package Code: 14537-408-50 Isoplate

NDC Package 14537-408-50 Isoplate

Sodium Chloride,Sodium Gluconate,Sodium Acetate,Potassium Chloride,Magnesium - 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:
14537-408-50
Package Description:
18 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER
Product Code:
14537-408
Proprietary Name:
Isoplate
Non-Proprietary Name:
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic
Substance Name:
Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Monobasic; Sodium Acetate; Sodium Chloride; Sodium Gluconate; Sodium Phosphate, Dibasic, Unspecified Form
Usage Information:
ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution to replace a portion of the plasma to store Platelets Pheresis Platelet Additive Solution (PAS) Added Leukocytes Reduced products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system [See Dosage and Administration (2).]Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% ISOPLATE SOLUTION and 35% plasma. Platelets in the solution can be stored at a concentration range of 0.7 to 2.1 × 106/µL for up to 5 days at 20-24 °C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)] [See Clinical Studies (14).]
11-Digit NDC Billing Format:
14537040850
Product Type:
Human Prescription Drug
Labeler Name:
Terumo Bct Ltd.
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):
  • MAGNESIUM CHLORIDE .03 g/100mL
  • POTASSIUM CHLORIDE .037 g/100mL
  • POTASSIUM PHOSPHATE, MONOBASIC .00082 g/100mL
  • SODIUM ACETATE .37 g/100mL
  • SODIUM CHLORIDE .53 g/100mL
  • SODIUM GLUCONATE .5 g/100mL
  • SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM .008 g/100mL
    • Pharmacologic Class(es):
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    BN090067
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-05-2013
    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 14537-408-50?

    The NDC Packaged Code 14537-408-50 is assigned to a package of 18 container in 1 case / 500 ml in 1 container of Isoplate, a human prescription drug labeled by Terumo Bct Ltd.. The product's dosage form is solution and is administered via intravenous form.

    Is NDC 14537-408 included in the NDC Directory?

    Yes, Isoplate with product code 14537-408 is active and included in the NDC Directory. The product was first marketed by Terumo Bct Ltd. on March 05, 2013 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 14537-408-50?

    The 11-digit format is 14537040850. 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 5-3-2 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
    5-3-214537-408-505-4-214537-0408-50