Infasurf Suspension
NDC Package 61938-456-06

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

Package Information

Infasurf (calfactant) suspension is iNDICATIONS AND USAGEInfasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment (“rescue”) of premature infants who develop RDS. This formulation utilizes a suspension delivery system. Marketed by Ony Biotech Inc., this product is identified by NDC 61938-456 and is authorized under FDA application BLA020521.

Identification & Billing

NDC Package Code
61938-456-06
Package Description
1 VIAL, GLASS in 1 CARTON / 6 mL in 1 VIAL, GLASS
Product Code
61938-456
11-Digit Billing Format
61938045606
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Infasurf
Non-Proprietary Name
Calfactant
Substance Name
Calfactant
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Endotracheal - Administration directly into the trachea.
Active Ingredient(s)
CALFACTANT 35.7 mg/mL
Pharmacologic Class
Usage Information
INDICATIONS AND USAGEInfasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment (“rescue”) of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS.ProphylaxisProphylaxis therapy at birth with Infasurf is indicated for premature infants less than 29 weeks of gestational age at significant risk for RDS. Infasurf prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth.TreatmentInfasurf therapy is indicated for infants less than or equal to 72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.

Regulatory & Marketing

Labeler Name
Ony Biotech Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA020521
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-18-1999
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61938-456). Click a package code to view its specific billing and regulatory data.

61938-456-03
1 VIAL, GLASS in 1 CARTON / 3 mL in 1 VIAL, GLASS

* 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 61938-456-06 identifies a specific commercial package of 1 vial, glass in 1 carton / 6 ml in 1 vial, glass of Infasurf, a human prescription drug labeled by Ony Biotech Inc.. This suspension is formulated for endotracheal use and contains calfactant 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 Ony Biotech Inc. on October 18, 1999. The current certification is valid through December 31, 2027.

How is this Ony Biotech Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61938045606. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
61938-456-06
11-Digit CMS (5-4-2)
61938-0456-06

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