enjaymo

Generic: sutimlimab-jome

Labeler: recordati rare diseases, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name enjaymo
Generic Name sutimlimab-jome
Labeler recordati rare diseases, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

sutimlimab 50 mg/mL

Manufacturer
Recordati Rare Diseases, Inc.

Identifiers & Regulatory

Product NDC 55292-820
Product ID 55292-820_fb86733b-25b0-48ca-97a0-8cb15eef1848
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761164
Listing Expiration 2027-12-31
Marketing Start 2022-02-04

Pharmacologic Class

Established (EPC)
classical complement pathway inhibitor [epc]
Mechanism of Action
classical complement pathway inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55292820
Hyphenated Format 55292-820

Supplemental Identifiers

RxCUI
2591419 2591425
UNII
GNWE7KJ995
NUI
N0000193991 N0000193990

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name enjaymo (source: ndc)
Generic Name sutimlimab-jome (source: ndc)
Application Number BLA761164 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55292-820-01) / 22 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

sutimlimab (50 mg/mL)

Linked Drug Pages (1)

Enjaymo ndc-match (0.9)

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"}