Crysvita Injection
NDC Package 42747-102-01

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

Crysvita (burosumab) injection is cRYSVITA is contraindicated:In concomitant use with oral phosphate and/or active vitamin D analogs (e.g. This formulation utilizes a injection delivery system. Marketed by Kyowa Kirin, Inc., this product is identified by NDC 42747-102 and is authorized under FDA application BLA761068.

Identification & Billing

NDC Package Code
42747-102-01
Package Description
1 mL in 1 VIAL, SINGLE-USE
Product Code
42747-102
11-Digit Billing Format
42747010201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Crysvita
Non-Proprietary Name
Burosumab
Substance Name
Burosumab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
BUROSUMAB 10 mg/mL
Usage Information
CRYSVITA is contraindicated:In concomitant use with oral phosphate and/or active vitamin D analogs (e.g. calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia [see Warnings and Precautions (5.2) and Drug Interactions (7.1)].When serum phosphorus is within or above the normal range for age [see Warnings and Precautions (5.2)].In patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism [see Use In Specific Population (8.6)].

Regulatory & Marketing

Labeler Name
Kyowa Kirin, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761068
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-18-2018
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.

J0584
Source: PDAC
INJECTION, BUROSUMAB-TWZA 1 MG
HCPCS Dosage 1 MG
Units / Pkg

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 42747-102-01 identifies a specific commercial package of 1 ml in 1 vial, single-use of Crysvita, a human prescription drug labeled by Kyowa Kirin, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 1 billable units per package. This injection is formulated for subcutaneous use and contains burosumab 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 Kyowa Kirin, Inc. on April 18, 2018. The current certification is valid through December 31, 2026.

How is this Kyowa Kirin, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42747010201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1 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 (5-3-2)
42747-102-01
11-Digit CMS (5-4-2)
42747-0102-01

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