Synagis
NDC Package 60574-4113-1

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.

Synagis is palivizumab is used in certain infants and young children to prevent serious lung infections (such as pneumonia) that are caused by a certain virus (respiratory syncytial virus-RSV). Marketed by Medimmune, Llc, this product is identified by NDC 60574-4113 and is authorized under FDA application BLA103770.

Identification & Billing

NDC Package Code
60574-4113-1
Package Description
1 mL in 1 VIAL, SINGLE-DOSE
Product Code
60574-4113
11-Digit Billing Format
60574411301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1 ML

Clinical Specifications

Proprietary Name
Synagis
Dosage Form
-
Usage Information
Palivizumab is used in certain infants and young children to prevent serious lung infections (such as pneumonia) that are caused by a certain virus (respiratory syncytial virus-RSV). Palivizumab works by preventing the growth of the virus. This medication is not used to treat RSV infection, but should be continued even if your child gets the RSV infection to prevent a more serious infection.

Regulatory & Marketing

Labeler Name
Medimmune, Llc
FDA Application #
BLA103770
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-19-1998
End Marketing Date
01-15-2021
Listing Expiration
01-15-2021
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 60574-4113-1 identifies a specific commercial package of 1 ml in 1 vial, single-dose of Synagis, labeled by Medimmune, Llc. This product is billed per "ML" milliliter 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 Medimmune, Llc on June 19, 1998. The current certification is valid through January 15, 2021.

What are the primary indications for this medication?

Palivizumab is used in certain infants and young children to prevent serious lung infections (such as pneumonia) that are caused by a certain virus (respiratory syncytial virus-RSV). Palivizumab works by preventing the growth of the virus. This medication is not used to treat RSV infection, but should be continued even if your child gets the RSV infection to prevent a more serious infection.

How is this Medimmune, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60574411301. 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 (5-4-1)
60574-4113-1
11-Digit CMS (5-4-2)
60574-4113-01

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