Package 10122-510-03

Brand: curosurf

Generic: poractant alfa
NDC Package

Package Facts

Identity

Package NDC 10122-510-03
Digits Only 1012251003
Product NDC 10122-510
Description

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

Marketing

Marketing Status
Marketed Since 1999-11-18
Brand curosurf
Generic poractant alfa
Sample Package No

Linked Drug Pages (1)

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"}