Cablivi Kit
NDC 58468-0225

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 58468-0225?
  4. Cablivi Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

Cablivi (caplacizumab) is a BLA-approved product labeled by Genzyme Corporation. This medication is used to treat a certain blood disorder (acquired thrombotic thrombocytopenic purpura-aTTP). It is supplied as a kit. This product entry covers the primary NDC 58468-0225 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58468-0225
Proprietary Name:
Cablivi
Non-Proprietary Name: [1]
Caplacizumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Genzyme Corporation
Labeler Code:
58468
Product Label ID:
2348f06e-8004-4040-832e-e9e86a39f905
HCPCS Code:
C9047 - Injection, caplacizumab-yhdp
FDA Application Number: [6]
BLA761112
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
02-06-2019
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 58468-0225?

The NDC code 58468-0225 is assigned by the FDA to the product Cablivi. It is commonly known by its generic name, caplacizumab. This pharmaceutical product is labeled by Genzyme Corporation and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 58468-0225-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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

Patient Education

Caplacizumab-yhdp Injection


Caplacizumab-yhdp injection is used to treat acquired thrombotic thrombocytopenic purpura (aTTP; a disorder in which the body attacks itself and causes clots, low amounts of platelets and red blood cells, and could cause other serious complications) in combination with plasma exchange therapy and immunosuppressant medications. Caplacizumab-yhdp is in a class of medications called antithrombotic agents. It works by blocking the action of a certain substance in the body that causes the symptoms of aTTP.
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Blood Thinners


What are blood thinners?

Blood thinners are medicines that prevent blood clots from forming. They do not break up clots that you already have. But they can stop those clots from getting bigger. It's important to treat blood clots, because clots in your blood vessels and heart can cause heart attacks, strokes, and blockages.

Who needs blood thinners?

You may need a blood thinner if you have:

What are the different types of blood thinners?

There are different types of blood thinners:

  • Anticoagulants, such as heparin or warfarin (also called Coumadin), slow down your body's process of making clots.
  • Antiplatelets, such as aspirin and clopidogrel, prevent blood cells called platelets from clumping together to form a clot. Antiplatelets are mainly taken by people who have had a heart attack or stroke.

How can I take blood thinners safely?

When you take a blood thinner, follow the directions carefully. Blood thinners may interact with certain foods, medicines, vitamins, and alcohol. Make sure that your health care provider knows all of the medicines and supplements you are using.

You may need regular blood tests to check how well your blood is clotting. It is important to make sure that you're taking enough medicine to prevent clots, but not so much that it causes bleeding.

What are the side effects of blood thinners?

Bleeding is the most common side effect of blood thinners. They can also cause an upset stomach, nausea, and diarrhea.

Other possible side effects can depend on which type of blood thinner that you are taking.

Call your provider if you have any sign of serious bleeding, such as:

  • Menstrual bleeding that is much heavier than normal
  • Red or brown urine
  • Bowel movements that are red or black
  • Bleeding from the gums or nose that does not stop quickly
  • Vomit that is brown or bright red
  • Coughing up something red
  • Severe pain, such as a headache or stomachache
  • Unusual bruising
  • A cut that does not stop bleeding
  • A serious fall or bump on the head
  • Dizziness or weakness

[Learn More]


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

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".