Sylatron
NDC Package 0085-4348-01

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.

Sylatron is a medication used to keep malignant melanoma (a type of skin cancer) from coming back after it has been removed by surgery. Marketed by Merck Sharp & Dohme Corp., this product is identified by NDC 0085-4348 and is authorized under FDA application BLA103949.

Identification & Billing

NDC Package Code
0085-4348-01
Package Description
1 KIT in 1 CARTON * .1 mL in 1 VIAL * 5 mL in 1 VIAL
Product Code
0085-4348
11-Digit Billing Format
00085434801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Sylatron
Dosage Form
-
Usage Information
This medication is used to keep malignant melanoma (a type of skin cancer) from coming back after it has been removed by surgery. This medication is the same as a protein that your body naturally makes (interferon). This medication is thought to work by affecting how cells work and grow and by affecting the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off cancer.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Corp.
FDA Application #
BLA103949
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-29-2011
End Marketing Date
10-18-2020
Listing Expiration
10-18-2020
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 0085-4348-01 identifies a specific commercial package of 1 kit in 1 carton * .1 ml in 1 vial * 5 ml in 1 vial of Sylatron, labeled by Merck Sharp & Dohme Corp.. 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 Merck Sharp & Dohme Corp. on March 29, 2011. The current certification is valid through October 18, 2020.

What are the primary indications for this medication?

This medication is used to keep malignant melanoma (a type of skin cancer) from coming back after it has been removed by surgery. This medication is the same as a protein that your body naturally makes (interferon). This medication is thought to work by affecting how cells work and grow and by affecting the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off cancer.

How is this Merck Sharp & Dohme Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00085434801. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
0085-4348-01
11-Digit CMS (5-4-2)
00085-4348-01

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