Home NDC 55292-820 Enjaymo
Product NDC 55292-820
11-digit product format 552920820
Labeler code 55292
Product ID 55292-820_fb86733b-25b0-48ca-97a0-8cb15eef1848
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sutimlimab-jome
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Recordati Rare Diseases, Inc.
Application BLA761164
Marketing category BLA
Marketing start 2022-02-04
Substance SUTIMLIMAB
Active strength 50 mg/mL
Pharmacologic classes Classical Complement Pathway Inhibitor [EPC], Classical Complement Pathway Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Enjaymo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUTIMLIMAB 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GNWE7KJ995 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2591419 Internal RxNorm lookup 2591425 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55292-820-01 Enjaymo 22 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 22 4 55292-820-01 Enjaymo 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55292-820 ENJAYMO (SUTIMLIMAB-JOME) INJECTION, SOLUTION, CONCENTRATE [RECORDATI RARE DISEASES, INC.] 1 Current NDC, 2 package rows 20250110_0a25363a-7781-d9f8-cb1c-be22987bf03b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761164 Enjaymo sutimlimab-jome 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 55292-820-01 55292082001 1 VIAL, SINGLE-DOSE in 1 CARTON (55292-820-01) / 22 mL in 1 VIAL, SINGLE-DOSE 2025-06-25 No No Current