Zevalin Kit
NDC Package 72893-007-04

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

Package Information

Zevalin (ibritumomab tiuxetan) kits is a clearly-labeled kit is required for preparation of Yttrium-90 (Y-90) Zevalin. This formulation utilizes a kit delivery system. Marketed by Acrotech Biopharma Inc, this product is identified by NDC 72893-007 and is authorized under FDA application BLA125019.

Identification & Billing

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
11-Digit Billing Format
72893000704
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Zevalin
Non-Proprietary Name
Ibritumomab Tiuxetan
Dosage Form
Kit - A packaged collection of related material.
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.

Regulatory & Marketing

Labeler Name
Acrotech Biopharma Inc
Product Type
Human Prescription Drug
FDA Application #
BLA125019
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-19-2002
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.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

A9543
Source: OPPS
Y90 ibritumomab, rx
HCPCS Dosage UP TO 40 millicuries
Units / Pkg 1

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 72893-007-04 identifies a specific commercial 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. This kit is formulated for use and contains 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 Acrotech Biopharma Inc on February 19, 2002. The current certification is valid through December 31, 2026.

How is this Acrotech Biopharma Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72893000704. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
72893-007-04
11-Digit CMS (5-4-2)
72893-0007-04

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