curosurf

Generic: poractant alfa

Labeler: chiesi usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name curosurf
Generic Name poractant alfa
Labeler chiesi usa, inc.
Dosage Form SUSPENSION
Routes
ENDOTRACHEAL
Active Ingredients

poractant alfa 80 mg/mL

Manufacturer
Chiesi USA, Inc.

Identifiers & Regulatory

Product NDC 10122-510
Product ID 10122-510_6b713a41-2648-43f4-9a10-cc41a7e83ca0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA020744
Listing Expiration 2026-12-31
Marketing Start 1999-11-18

Pharmacologic Class

Established (EPC)
surfactant [epc]
Mechanism of Action
surfactant activity [moa]
Physiologic Effect
alveolar surface tension reduction [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10122510
Hyphenated Format 10122-510

Supplemental Identifiers

RxCUI
259216 261329
UNII
KE3U2023NP
NUI
N0000008294 N0000175778 N0000000079

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name curosurf (source: ndc)
Generic Name poractant alfa (source: ndc)
Application Number BLA020744 (source: ndc)
Routes
ENDOTRACHEAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
source: ndc
Packaging
  • 1.5 mL in 1 VIAL, GLASS (10122-510-01)
  • 3 mL in 1 VIAL, GLASS (10122-510-03)
source: ndc

Packages (2)

10122-510-01 1.5 mL in 1 VIAL, GLASS (10122-510-01) 10122-510-03 3 mL in 1 VIAL, GLASS (10122-510-03)

Ingredients (1)

poractant alfa (80 mg/mL)

Linked Drug Pages (1)

Curosurf ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ENDOTRACHEAL"], "spl_id": "6b713a41-2648-43f4-9a10-cc41a7e83ca0", "openfda": {"nui": ["N0000008294", "N0000175778", "N0000000079"], "unii": ["KE3U2023NP"], "rxcui": ["259216", "261329"], "spl_set_id": ["99bef307-00bd-4379-9f45-ede1380e74d4"], "pharm_class_pe": ["Alveolar Surface Tension Reduction [PE]"], "pharm_class_epc": ["Surfactant [EPC]"], "pharm_class_moa": ["Surfactant Activity [MoA]"], "manufacturer_name": ["Chiesi USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1.5 mL in 1 VIAL, GLASS (10122-510-01)", "package_ndc": "10122-510-01", "marketing_start_date": "19991118"}, {"sample": false, "description": "3 mL in 1 VIAL, GLASS (10122-510-03)", "package_ndc": "10122-510-03", "marketing_start_date": "19991118"}], "brand_name": "Curosurf", "product_id": "10122-510_6b713a41-2648-43f4-9a10-cc41a7e83ca0", "dosage_form": "SUSPENSION", "pharm_class": ["Alveolar Surface Tension Reduction [PE]", "Surfactant Activity [MoA]", "Surfactant [EPC]"], "product_ndc": "10122-510", "generic_name": "poractant alfa", "labeler_name": "Chiesi USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Curosurf", "active_ingredients": [{"name": "PORACTANT ALFA", "strength": "80 mg/mL"}], "application_number": "BLA020744", "marketing_category": "BLA", "marketing_start_date": "19991118", "listing_expiration_date": "20261231"}