Synagis Injection, Solution
NDC Package 66658-231-01

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Synagis (palivizumab) injection 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). This formulation utilizes a injection, solution delivery system. Marketed by Swedish Orphan Biovitrum Ab (publ), this product is identified by NDC 66658-231 and is authorized under FDA application BLA103770.

Identification & Billing

NDC Package Code
66658-231-01
Package Description
1 mL in 1 VIAL, SINGLE-DOSE
Product Code
66658-231
11-Digit Billing Format
66658023101
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
Synagis
Non-Proprietary Name
Palivizumab
Substance Name
Palivizumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
PALIVIZUMAB 100 mg/mL
Pharmacologic Class
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
Swedish Orphan Biovitrum Ab (publ)
Product Type
Human Prescription Drug
FDA Application #
BLA103770
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-19-1998
End Marketing Date
07-31-2026
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 66658-231-01 identifies a specific commercial package of 1 ml in 1 vial, single-dose of Synagis, a human prescription drug labeled by Swedish Orphan Biovitrum Ab (publ). This product is billed per "ML" milliliter and contains an estimated amount of 1 billable units per package. This injection, solution is formulated for intramuscular use and contains palivizumab 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 Swedish Orphan Biovitrum Ab (publ) on June 19, 1998.

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 Swedish Orphan Biovitrum Ab (publ) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66658023101. 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)
66658-231-01
11-Digit CMS (5-4-2)
66658-0231-01

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