Curosurf Suspension
NDC Package 10122-510-01

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

Curosurf (poractant alfa) suspension is cUROSURF® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants.  CUROSURF reduces mortality and pneumothoraces associated with RDS. This formulation utilizes a suspension delivery system. Marketed by Chiesi Usa, Inc., this product is identified by NDC 10122-510 and is authorized under FDA application BLA020744.

Identification & Billing

NDC Package Code
10122-510-01
Package Description
1.5 mL in 1 VIAL, GLASS
Product Code
10122-510
11-Digit Billing Format
10122051001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1.5 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Curosurf
Non-Proprietary Name
Poractant Alfa
Substance Name
Poractant Alfa
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)
PORACTANT ALFA 80 mg/mL
Pharmacologic Class
Usage Information
CUROSURF® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (RDS) in premature infants.  CUROSURF reduces mortality and pneumothoraces associated with RDS.

Regulatory & Marketing

Labeler Name
Chiesi Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA020744
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-18-1999
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10122-510). Click a package code to view its specific billing and regulatory data.

10122-510-03
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 10122-510-01 identifies a specific commercial package of 1.5 ml in 1 vial, glass of Curosurf, a human prescription drug labeled by Chiesi Usa, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 1.5 billable units per package. This suspension is formulated for endotracheal use and contains poractant alfa 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 Chiesi Usa, Inc. on November 18, 1999. The current certification is valid through December 31, 2026.

How is this Chiesi Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10122051001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1.5 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)
10122-510-01
11-Digit CMS (5-4-2)
10122-0510-01

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