NDC 10122-510

Curosurf

Poractant Alfa

Curosurf is a Endotracheal Suspension in the Human Prescription Drug category. It is labeled and distributed by Chiesi Usa, Inc.. The primary component is Poractant Alfa.

• Product ID: 10122-510_3d9f7081-a055-4a04-8320-3eac7696f5a1
• NDC: 10122-510
• Product Type: Human Prescription Drug
• Proprietary Name: Curosurf
• Generic Name: Poractant Alfa
• Dosage Form: Suspension
• Route of Administration: ENDOTRACHEAL
• Marketing Start Date: 1999-11-18
• Marketing Category: BLA / NDA
• Application Number: BLA020744
• Labeler Name: Chiesi USA, Inc.
• Substance Name: PORACTANT ALFA
• Active Ingredient Strength: 80 mg/mL
• Pharm Classes: Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 10122-510-01

1.5 mL in 1 VIAL, GLASS (10122-510-01)

• Marketing Start Date: 1999-11-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10122-510-03 [10122051003]

Curosurf SUSPENSION

• Marketing Category: BLA
• Application Number: BLA020744
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1999-11-18

NDC 10122-510-01 [10122051001]

Curosurf SUSPENSION

• Marketing Category: BLA
• Application Number: BLA020744
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1999-11-18

Drug Details

Active Ingredients

Ingredient	Strength
PORACTANT ALFA	80 mg/mL

OpenFDA Data

• SPL SET ID: 99bef307-00bd-4379-9f45-ede1380e74d4
• Manufacturer:
  • Chiesi USA, Inc.
• UNII:
  • KE3U2023NP
• RxNorm Concept Unique ID - RxCUI:
  • 261329
  • 259216

Pharmacological Class

• Alveolar Surface Tension Reduction [PE]
• Surfactant [EPC]
• Surfactant Activity [MoA]