bkemv

Generic: eculizumab-aeeb

Labeler: amgen inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name bkemv
Generic Name eculizumab-aeeb
Labeler amgen inc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

eculizumab 300 mg/30mL

Manufacturer
Amgen Inc

Identifiers & Regulatory

Product NDC 55513-180
Product ID 55513-180_20150720-3435-4d6c-8eb1-55e6bc56cdce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761333
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

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 55513180
Hyphenated Format 55513-180

Supplemental Identifiers

RxCUI
2706351 2706358
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 bkemv (source: ndc)
Generic Name eculizumab-aeeb (source: ndc)
Application Number BLA761333 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/30mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (55513-180-01) / 30 mL in 1 VIAL
source: ndc

Packages (1)

55513-180-01 1 VIAL in 1 CARTON (55513-180-01) / 30 mL in 1 VIAL

Ingredients (1)

eculizumab (300 mg/30mL)

Linked Drug Pages (1)

BKEMV ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "20150720-3435-4d6c-8eb1-55e6bc56cdce", "openfda": {"nui": ["N0000175575", "N0000175974"], "unii": ["A3ULP0F556"], "rxcui": ["2706351", "2706358"], "spl_set_id": ["002f9748-b0e8-4b6e-a38b-56930a839491"], "pharm_class_epc": ["Complement Inhibitor [EPC]"], "pharm_class_moa": ["Complement Inhibitors [MoA]"], "manufacturer_name": ["Amgen Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (55513-180-01)  / 30 mL in 1 VIAL", "package_ndc": "55513-180-01", "marketing_start_date": "20250301"}], "brand_name": "BKEMV", "product_id": "55513-180_20150720-3435-4d6c-8eb1-55e6bc56cdce", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Complement Inhibitor [EPC]", "Complement Inhibitors [MoA]"], "product_ndc": "55513-180", "generic_name": "eculizumab-aeeb", "labeler_name": "Amgen Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BKEMV", "active_ingredients": [{"name": "ECULIZUMAB", "strength": "300 mg/30mL"}], "application_number": "BLA761333", "marketing_category": "BLA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}