Cablivi Kit
NDC Package 58468-0225-1

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

Cablivi (caplacizumab) kits is a medication used to treat a certain blood disorder (acquired thrombotic thrombocytopenic purpura-aTTP). This formulation utilizes a kit delivery system. Marketed by Genzyme Corporation, this product is identified by NDC 58468-0225 and is authorized under FDA application BLA761112.

Identification & Billing

NDC Package Code
58468-0225-1
Package Description
1 KIT in 1 CARTON * 1 mL in 1 VIAL, GLASS (58468-0227-1) * 1 mL in 1 SYRINGE, GLASS (58468-0229-1)
Product Code
58468-0225
11-Digit Billing Format
58468022501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cablivi
Non-Proprietary Name
Caplacizumab
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to treat a certain blood disorder (acquired thrombotic thrombocytopenic purpura-aTTP). It is used in combination with certain other treatments for this disorder (plasma exchange, immune suppressing medication). In aTTP, blood clots form in small blood vessels throughout the body. These clots can cause serious medical problems if they block vessels and limit or stop blood flow to organs such as the brain, kidneys, and heart. This disorder can also cause red blood cells to break apart faster than the body can replace them, which results in anemia. Caplacizumab-yhdp works by causing your body to make fewer/smaller blood clots.

Regulatory & Marketing

Labeler Name
Genzyme Corporation
Product Type
Human Prescription Drug
FDA Application #
BLA761112
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-06-2019
Listing Expiration
12-31-2027
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.

C9047
Source: OPPS
Injection, caplacizumab-yhdp
HCPCS Dosage 1 MG
Units / Pkg 11

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 58468-0225-1 identifies a specific commercial package of 1 kit in 1 carton * 1 ml in 1 vial, glass (58468-0227-1) * 1 ml in 1 syringe, glass (58468-0229-1) of Cablivi, a human prescription drug labeled by Genzyme Corporation. 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 Genzyme Corporation on February 06, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a certain blood disorder (acquired thrombotic thrombocytopenic purpura-aTTP). It is used in combination with certain other treatments for this disorder (plasma exchange, immune suppressing medication). In aTTP, blood clots form in small blood vessels throughout the body. These clots can cause serious medical problems if they block vessels and limit or stop blood flow to organs such as the brain, kidneys, and heart. This disorder can also cause red blood cells to break apart faster than the body can replace them, which results in anemia. Caplacizumab-yhdp works by causing your body to make fewer/smaller blood clots.

How is this Genzyme Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58468022501. 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 (5-4-1)
58468-0225-1
11-Digit CMS (5-4-2)
58468-0225-01

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