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  5. NDC Package Code: 61938-456-06 Infasurf

NDC Package 61938-456-06 Infasurf

Calfactant Suspension Endotracheal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
61938-456-06
Package Description:
1 VIAL, GLASS in 1 CARTON / 6 mL in 1 VIAL, GLASS
Product Code:
61938-456
Proprietary Name:
Infasurf
Non-Proprietary Name:
Calfactant
Substance Name:
Calfactant
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.
11-Digit NDC Billing Format:
61938045606
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 259611 - calfactant 35 MG/ML Intratracheal Suspension
  • RxCUI: 994039 - INFASURF 35 MG/mL Intratracheal Suspension
  • RxCUI: 994039 - calfactant 35 MG/ML Intratracheal Suspension [Infasurf]
  • RxCUI: 994039 - Infasurf 35 MG/ML Intratracheal Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ony Biotech Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Endotracheal - Administration directly into the trachea.
    • Active Ingredient(s):
  • CALFACTANT 35.7 mg/mL
    • Pharmacologic Class(es):
  • Alveolar Surface Tension Reduction - [PE] (Physiologic Effect)
  • Surfactant Activity - [MoA] (Mechanism of Action)
  • Surfactant - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA020521
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-21-2011
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    61938-456-031 VIAL, GLASS in 1 CARTON / 3 mL in 1 VIAL, GLASS

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61938-456-06?

    The NDC Packaged Code 61938-456-06 is assigned to a 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.. The product's dosage form is suspension and is administered via endotracheal form.

    Is NDC 61938-456 included in the NDC Directory?

    Yes, Infasurf with product code 61938-456 is active and included in the NDC Directory. The product was first marketed by Ony Biotech Inc. on July 21, 2011 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 61938-456-06?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 61938-456-06?

    The 11-digit format is 61938045606. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-261938-456-065-4-261938-0456-06