ultomiris

Generic: ravulizumab

Labeler: alexion pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ultomiris
Generic Name ravulizumab
Labeler alexion pharmaceuticals inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

ravulizumab 300 mg/3mL

Manufacturer
Alexion Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 25682-025
Product ID 25682-025_41262953-a849-4095-b9c2-5a1d8b0238cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761108
Listing Expiration 2026-12-31
Marketing Start 2020-10-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25682025
Hyphenated Format 25682-025

Supplemental Identifiers

RxCUI
2107320 2107325 2461134 2461136 2461139 2461140
UNII
C3VX249T6L
NUI
N0000175575 N0000175974

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 ultomiris (source: ndc)
Generic Name ravulizumab (source: ndc)
Application Number BLA761108 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/3mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (25682-025-01) / 3 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

25682-025-01 1 VIAL, GLASS in 1 CARTON (25682-025-01) / 3 mL in 1 VIAL, GLASS

Ingredients (1)

ravulizumab (300 mg/3mL)

Linked Drug Pages (1)

Ultomiris ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "41262953-a849-4095-b9c2-5a1d8b0238cc", "openfda": {"nui": ["N0000175575", "N0000175974"], "unii": ["C3VX249T6L"], "rxcui": ["2107320", "2107325", "2461134", "2461136", "2461139", "2461140"], "spl_set_id": ["a9a590d9-0217-43c7-908d-e62a71279791"], "pharm_class_epc": ["Complement Inhibitor [EPC]"], "pharm_class_moa": ["Complement Inhibitors [MoA]"], "manufacturer_name": ["Alexion Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (25682-025-01)  / 3 mL in 1 VIAL, GLASS", "package_ndc": "25682-025-01", "marketing_start_date": "20201009"}], "brand_name": "Ultomiris", "product_id": "25682-025_41262953-a849-4095-b9c2-5a1d8b0238cc", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Complement Inhibitor [EPC]", "Complement Inhibitors [MoA]"], "product_ndc": "25682-025", "generic_name": "ravulizumab", "labeler_name": "Alexion Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ultomiris", "active_ingredients": [{"name": "RAVULIZUMAB", "strength": "300 mg/3mL"}], "application_number": "BLA761108", "marketing_category": "BLA", "marketing_start_date": "20201009", "listing_expiration_date": "20261231"}