Sylvant
NDC Package 57894-421-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Sylvant is siltuximab is used to treat a certain rare illness (multicentric Castleman's disease - MCD) if you do not have HIV or herpes infections. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-421 and is authorized under FDA application BLA125496.

Identification & Billing

NDC Package Code
57894-421-01
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
Product Code
57894-421
11-Digit Billing Format
57894042101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Sylvant
Dosage Form
-
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
Janssen Biotech, Inc.
FDA Application #
BLA125496
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-01-2014
End Marketing Date
01-31-2021
Listing Expiration
01-31-2021
Exclude Flag
D
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 57894-421-01 identifies a specific commercial package of 1 vial, single-use in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-use of Sylvant, labeled by Janssen Biotech, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Janssen Biotech, Inc. on April 01, 2014. The current certification is valid through January 31, 2021.

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 Janssen Biotech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894042101. 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)
57894-421-01
11-Digit CMS (5-4-2)
57894-0421-01

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