Package 47783-101-01
Brand: kalbitor
Generic: ecallantidePackage Facts
Identity
Package NDC
47783-101-01
Digits Only
4778310101
Product NDC
47783-101
Description
3 VIAL, GLASS in 1 CARTON (47783-101-01) / 1 mL in 1 VIAL, GLASS
Marketing
Marketing Status
Brand
kalbitor
Generic
ecallantide
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["SUBCUTANEOUS"], "spl_id": "1992039f-246f-4057-899b-987d45df152f", "openfda": {"nui": ["N0000192750", "N0000184151"], "unii": ["5Q6TZN2HNM"], "rxcui": ["884698", "884702"], "spl_set_id": ["f56aec67-c662-477c-b866-bfc23e8809cf"], "pharm_class_epc": ["Plasma Kallikrein Inhibitor [EPC]"], "pharm_class_moa": ["Kallikrein Inhibitors [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL, GLASS in 1 CARTON (47783-101-01) / 1 mL in 1 VIAL, GLASS", "package_ndc": "47783-101-01", "marketing_start_date": "20100202"}], "brand_name": "Kalbitor", "product_id": "47783-101_1992039f-246f-4057-899b-987d45df152f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Kallikrein Inhibitors [MoA]", "Plasma Kallikrein Inhibitor [EPC]"], "product_ndc": "47783-101", "generic_name": "Ecallantide", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kalbitor", "active_ingredients": [{"name": "ECALLANTIDE", "strength": "10 mg/mL"}], "application_number": "BLA125277", "marketing_category": "BLA", "marketing_start_date": "20100202", "listing_expiration_date": "20261231"}