Sylvant Injection, Powder, For Solution
NDC Package 73090-421-01

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

Package Information

Sylvant (siltuximab) injection is siltuximab is used to treat a certain rare illness (multicentric Castleman's disease - MCD) if you do not have HIV or herpes infections. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Recordati Rare Diseases, Inc., this product is identified by NDC 73090-421 and is authorized under FDA application BLA125496.

Identification & Billing

NDC Package Code
73090-421-01
Package Description
1 VIAL, SINGLE-DOSE in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Product Code
73090-421
11-Digit Billing Format
73090042101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sylvant
Non-Proprietary Name
Siltuximab
Substance Name
Siltuximab
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
SILTUXIMAB 400 mg/1
Pharmacologic Class
Usage Information
Siltuximab is used to treat a certain rare illness (multicentric Castleman's disease - MCD) if you do not have HIV or herpes infections. Siltuximab blocks a certain natural substance that affects the immune system. Siltuximab can improve the symptoms of MCD including lumps under the skin, fever, weakness or tiredness, or night sweats.

Regulatory & Marketing

Labeler Name
Recordati Rare Diseases, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125496
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-23-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 73090-421-01 identifies a specific commercial package of 1 vial, single-dose in 1 box / 1 injection, powder, for solution in 1 vial, single-dose of Sylvant, a human prescription drug labeled by Recordati Rare Diseases, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, for solution is formulated for intravenous use and contains siltuximab 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 Recordati Rare Diseases, Inc. on April 23, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Siltuximab is used to treat a certain rare illness (multicentric Castleman's disease - MCD) if you do not have HIV or herpes infections. Siltuximab blocks a certain natural substance that affects the immune system. Siltuximab can improve the symptoms of MCD including lumps under the skin, fever, weakness or tiredness, or night sweats.

How is this Recordati Rare Diseases, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73090042101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
73090-421-01
11-Digit CMS (5-4-2)
73090-0421-01

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