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  5. NDC Package Code: 72893-007-04 Zevalin

NDC Package 72893-007-04 Zevalin

Ibritumomab Tiuxetan Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
72893-007-04
Package Description:
1 KIT in 1 CARTON * 10 mL in 1 VIAL * 2 mL in 1 VIAL * 2 mL in 1 VIAL
Product Code:
72893-007
Proprietary Name:
Zevalin
Non-Proprietary Name:
Ibritumomab Tiuxetan
Usage Information:
A clearly-labeled kit is required for preparation of Yttrium-90 (Y-90) Zevalin. Follow the detailed instructions for the preparation of radiolabeled Zevalin [see Dosage and Administration (2.4)].Required materials not supplied in the kit:1.Yttrium-90 Chloride Sterile Solution 2.Three sterile 1 mL plastic syringes3.One sterile 3 mL plastic syringe4.Two sterile 10 mL plastic syringes with 18-20 G needles5.ITLC silica gel strips6.0.9% Sodium Chloride aqueous solution for the chromatography solvent7.Developing chamber for chromatography8.Suitable radioactivity counting apparatus9.Filter, 0.22 micrometer, low-protein-binding10.Appropriate acrylic shielding for reaction vial and syringe for Y-90Method:1.Allow contents of the refrigerated Y-90 Zevalin kit (Zevalin vial, 50 mM sodium acetate vial, and formulation buffer vial) to reach room temperature. 2.Place the empty reaction vial in an appropriate acrylic shield.3.Determine the amount of each component needed:a.Calculate volume of Y-90 Chloride equivalent to 40 mCi based on the activity concentration of the Y-90 Chloride stock.b.The volume of 50 mM Sodium Acetate solution needed is 1.2 times the volume of Y-90 Chloride solution determined in step 3.a, above.c.Calculate the volume of formulation buffer needed to bring the reaction vial contents to a final volume of 10 mL.4.Transfer the calculated volume of 50 mM Sodium Acetate to the empty reaction vial. Coat the entire inner surface of the reaction vial by gentle inversion or rolling.5.Transfer 40 mCi of Y-90 Chloride to the reaction vial using an acrylic shielded syringe. Mix the two solutions by gentle inversion or rolling.6.Transfer 1.3 mL of Zevalin (ibritumomab tiuxetan) to the reaction vial. Do not shake or agitate the vial contents.7.Allow the labeling reaction to proceed at room temperature for 5 minutes. A shorter or longer reaction time may adversely alter the final labeled product.8.Immediately after the 5-minute incubation period, transfer the calculated volume of formulation buffer from step 3.c. to the reaction vial. Gently add the formulation buffer down the side of the reaction vial. If necessary, withdraw an equal volume of air to normalize pressure.9.Measure the final product for total activity using a radioactivity calibration system suitable for the measurement of Y-90.10.Using the supplied labels, record the date and time of preparation, the total activity and volume, and the date and time of expiration, and affix these labels to the shielded reaction vial container.11.Patient Dose: Calculate the volume required for a Y-90 Zevalin dose [see Dosage and Administration (2.2)].  Withdraw the required volume from the reaction vial. Assay the syringe in the dose calibrator suitable for the measurement of Y-90. The measured dose must be within 10% of the prescribed dose of Y-90 Zevalin and must not exceed 32 mCi (1184 MBq). Using the supplied labels, record the patient identifier, total activity and volume and the date and time of expiration, and affix these labels to the syringe and shielded unit dose container.12.Determine Radiochemical Purity [see Dosage and Administration (2.4)].13.Store Yttrium-90 Zevalin at 2-8°C (36-46°F) until use and administer within 8 hours of radiolabeling. Immediately prior to administration, assay the syringe and contents using a radioactivity calibration system suitable for the measurement of Y-90.
11-Digit NDC Billing Format:
72893000704
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Product Type:
Human Prescription Drug
Labeler Name:
Acrotech Biopharma Inc
Dosage Form:
Kit - A packaged collection of related material.
Sample Package:
No
FDA Application Number:
BLA125019
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
02-19-2002
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.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 72893-007-04 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
72893000704A9543Y90 ibritumomab, rxUP TO 40 millicuries1111

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Frequently Asked Questions

What is NDC 72893-007-04?

The NDC Packaged Code 72893-007-04 is assigned to a package of 1 kit in 1 carton * 10 ml in 1 vial * 2 ml in 1 vial * 2 ml in 1 vial of Zevalin, a human prescription drug labeled by Acrotech Biopharma Inc. The product's dosage form is kit and is administered via form.

Is NDC 72893-007 included in the NDC Directory?

Yes, Zevalin with product code 72893-007 is active and included in the NDC Directory. The product was first marketed by Acrotech Biopharma Inc on February 19, 2002 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 NDC billing unit for package 72893-007-04?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

What is the 11-digit format for NDC 72893-007-04?

The 11-digit format is 72893000704. 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
5-3-272893-007-045-4-272893-0007-04