Package 76431-210-01

Brand: myalept

Generic: metreleptin
NDC Package

Package Facts

Identity

Package NDC 76431-210-01
Digits Only 7643121001
Product NDC 76431-210
Product ID 76431-210_5654fc72-b7ad-420b-8173-f65ad5add4d3
Description

1 VIAL, GLASS in 1 CARTON (76431-210-01) / 2.2 mL in 1 VIAL, GLASS

Marketing

Marketing Status
Marketed Since 2015-03-05
Brand myalept
Generic metreleptin
Sample Package No

Linked Drug Pages (1)

Myalept ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "5654fc72-b7ad-420b-8173-f65ad5add4d3", "openfda": {"nui": ["N0000190854", "N0000175452", "N0000170333"], "unii": ["TL60C27RLH"], "rxcui": ["1491629", "1491634"], "spl_set_id": ["c986f93b-855d-4ef0-b620-5d41a0513e48"], "pharm_class_cs": ["Analogs/Derivatives [Chemical/Ingredient]", "Leptin [Chemical/Ingredient]"], "pharm_class_epc": ["Leptin Analog [EPC]"], "manufacturer_name": ["Amryt Pharmaceuticals Designated Activity Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (76431-210-01)  / 2.2 mL in 1 VIAL, GLASS", "package_ndc": "76431-210-01", "marketing_start_date": "20150305"}], "brand_name": "Myalept", "product_id": "76431-210_5654fc72-b7ad-420b-8173-f65ad5add4d3", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Analogs/Derivatives [Chemical/Ingredient]", "Leptin Analog [EPC]", "Leptin [Chemical/Ingredient]"], "product_ndc": "76431-210", "generic_name": "metreleptin", "labeler_name": "Amryt Pharmaceuticals Designated Activity Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Myalept", "active_ingredients": [{"name": "METRELEPTIN", "strength": "11.3 mg/2.2mL"}], "application_number": "BLA125390", "marketing_category": "BLA", "marketing_start_date": "20150305", "listing_expiration_date": "20261231"}