soliris

Generic: eculizumab

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

Drug Facts

Product Profile

Brand Name soliris
Generic Name eculizumab
Labeler alexion pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

eculizumab 300 mg/30mL

Manufacturer
Alexion Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 25682-001
Product ID 25682-001_25021c88-95e1-42f0-b895-921526b90642
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125166
Listing Expiration 2026-12-31
Marketing Start 2007-04-02

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 25682001
Hyphenated Format 25682-001

Supplemental Identifiers

RxCUI
700384 700387
UNII
A3ULP0F556
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 soliris (source: ndc)
Generic Name eculizumab (source: ndc)
Application Number BLA125166 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/30mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25682-001-01) / 30 mL in 1 VIAL
source: ndc

Packages (1)

25682-001-01 1 VIAL in 1 CARTON (25682-001-01) / 30 mL in 1 VIAL

Ingredients (1)

eculizumab (300 mg/30mL)

Linked Drug Pages (1)

SOLIRIS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "25021c88-95e1-42f0-b895-921526b90642", "openfda": {"nui": ["N0000175575", "N0000175974"], "unii": ["A3ULP0F556"], "rxcui": ["700384", "700387"], "spl_set_id": ["ebcd67fa-b4d1-4a22-b33d-ee8bf6b9c722"], "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 in 1 CARTON (25682-001-01)  / 30 mL in 1 VIAL", "package_ndc": "25682-001-01", "marketing_start_date": "20070402"}], "brand_name": "SOLIRIS", "product_id": "25682-001_25021c88-95e1-42f0-b895-921526b90642", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Complement Inhibitor [EPC]", "Complement Inhibitors [MoA]"], "product_ndc": "25682-001", "generic_name": "ECULIZUMAB", "labeler_name": "Alexion Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOLIRIS", "active_ingredients": [{"name": "ECULIZUMAB", "strength": "300 mg/30mL"}], "application_number": "BLA125166", "marketing_category": "BLA", "marketing_start_date": "20070402", "listing_expiration_date": "20261231"}