Adakveo Injection
NDC Package 0078-0883-61

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

Package Information

Adakveo (crizanlizumab) injection is aDAKVEO® is indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. This formulation utilizes a injection delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0883 and is authorized under FDA application BLA761128.

Identification & Billing

NDC Package Code
0078-0883-61
Package Description
10 mL in 1 VIAL, GLASS
Product Code
0078-0883
11-Digit Billing Format
00078088361
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Adakveo
Non-Proprietary Name
Crizanlizumab
Substance Name
Crizanlizumab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CRIZANLIZUMAB 10 mg/mL
Pharmacologic Class
Usage Information
ADAKVEO® is indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
BLA761128
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-15-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0078-0883-61 identifies a specific commercial package of 10 ml in 1 vial, glass of Adakveo, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 10 billable units per package. This injection is formulated for intravenous use and contains crizanlizumab 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 Novartis Pharmaceuticals Corporation on November 15, 2019. The current certification is valid through December 31, 2027.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078088361. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 total billable units per package. 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 (4-4-2)
0078-0883-61
11-Digit CMS (5-4-2)
00078-0883-61

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