Package 55292-820-01

Brand: enjaymo

Generic: sutimlimab-jome
NDC Package

Package Facts

Identity

Package NDC 55292-820-01
Digits Only 5529282001
Product NDC 55292-820
Product ID 55292-820_fb86733b-25b0-48ca-97a0-8cb15eef1848
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (55292-820-01) / 22 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2025-06-25
Brand enjaymo
Generic sutimlimab-jome
Sample Package No

Linked Drug Pages (1)

Enjaymo ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fb86733b-25b0-48ca-97a0-8cb15eef1848", "openfda": {"nui": ["N0000193991", "N0000193990"], "unii": ["GNWE7KJ995"], "rxcui": ["2591419", "2591425"], "spl_set_id": ["0a25363a-7781-d9f8-cb1c-be22987bf03b"], "pharm_class_epc": ["Classical Complement Pathway Inhibitor [EPC]"], "pharm_class_moa": ["Classical Complement Pathway Inhibitors [MoA]"], "manufacturer_name": ["Recordati Rare Diseases, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55292-820-01)  / 22 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55292-820-01", "marketing_start_date": "20250625"}], "brand_name": "Enjaymo", "product_id": "55292-820_fb86733b-25b0-48ca-97a0-8cb15eef1848", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Classical Complement Pathway Inhibitor [EPC]", "Classical Complement Pathway Inhibitors [MoA]"], "product_ndc": "55292-820", "generic_name": "sutimlimab-jome", "labeler_name": "Recordati Rare Diseases, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Enjaymo", "active_ingredients": [{"name": "SUTIMLIMAB", "strength": "50 mg/mL"}], "application_number": "BLA761164", "marketing_category": "BLA", "marketing_start_date": "20220204", "listing_expiration_date": "20271231"}