Prescription drug · BLA
Curosurf (poractant alfa) NDC 10122-510
Poractant alfa 80 mg/mL · Suspension · Endotracheal · Chiesi USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10122-510-01 | 10122051001 | 1.5 mL in 1 VIAL, GLASS (10122-510-01)Marketed from Nov 18, 1999 | |
| 10122-510-03 | 10122051003 | 3 mL in 1 VIAL, GLASS (10122-510-03)Marketed from Nov 18, 1999 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Curosurf
- Generic name (nonproprietary)
- poractant alfa
- Active ingredients
- Poractant alfa — 80 mg/mL
- Dosage form
- Suspension
- Route
- Endotracheal
- Labeler
- Chiesi USA, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 020744
- Marketing start
- Listing expires
- Other FDA classes
- Alveolar Surface Tension Reduction (Physiologic effect)Surfactant Activity (Mechanism)
- Identifiers
- Product ID 10122-510_6b713a41-2648-43f4-9a10-cc41a7e83ca0SPL ID 6b713a41-2648-43f4-9a10-cc41a7e83ca0SPL set ID 99bef307-00bd-4379-9f45-ede1380e74d4RxCUI 259216, 261329UNII KE3U2023NP
- Pharmacologic class
- Surfactant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N410122051001followed by a unit qualifier and the quantityPackage 10122-0510-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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. CUROSURF is a surfactant indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants. ( 1 )
Excerpt only. Read the full label for complete information.