Adzynma Kit
NDC Package 64764-145-05

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

Adzynma (apadamtase alfa) kits is aDZYNMA (ADAMTS13, recombinant-krhn) is a human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (rADAMTS13) indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP) [see Use in Specific Populations (8.4), Clinical Studies (14)]. This formulation utilizes a kit delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 64764-145 and is authorized under FDA application BLA125795.

Identification & Billing

NDC Package Code
64764-145-05
Package Description
1 KIT in 1 CARTON * 1500 [iU] in 1 VIAL, SINGLE-DOSE (64764-135-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)
Product Code
64764-145
11-Digit Billing Format
64764014505
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Adzynma
Non-Proprietary Name
Apadamtase Alfa
Dosage Form
Kit - A packaged collection of related material.
Usage Information
ADZYNMA (ADAMTS13, recombinant-krhn) is a human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (rADAMTS13) indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP) [see Use in Specific Populations (8.4), Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125795
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-09-2023
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.

J7171
Source: ASP
Inj, adzynma, 10 iu
HCPCS Dosage 10 UNITS
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 64764-145-05 identifies a specific commercial package of 1 kit in 1 carton * 1500 [iu] in 1 vial, single-dose (64764-135-01) * 5 ml in 1 vial, glass (64764-515-50) of Adzynma, a human prescription drug labeled by Takeda Pharmaceuticals America, 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 Takeda Pharmaceuticals America, Inc. on November 09, 2023. The current certification is valid through December 31, 2026.

How is this Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64764014505. 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)
64764-145-05
11-Digit CMS (5-4-2)
64764-0145-05

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