epysqli

Generic: eculizumab-aagh

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name epysqli
Generic Name eculizumab-aagh
Labeler teva pharmaceuticals usa, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

eculizumab 300 mg/30mL

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 51759-208
Product ID 51759-208_d3bb3a53-96c5-43e2-aba5-c5c971149741
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761340
Listing Expiration 2026-12-31
Marketing Start 2025-04-07

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 51759208
Hyphenated Format 51759-208

Supplemental Identifiers

RxCUI
2706338 2706345
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 epysqli (source: ndc)
Generic Name eculizumab-aagh (source: ndc)
Application Number BLA761340 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/30mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (51759-208-13) / 30 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

51759-208-13 1 VIAL, SINGLE-DOSE in 1 CARTON (51759-208-13) / 30 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

eculizumab (300 mg/30mL)

Linked Drug Pages (1)

EPYSQLI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d3bb3a53-96c5-43e2-aba5-c5c971149741", "openfda": {"nui": ["N0000175575", "N0000175974"], "unii": ["A3ULP0F556"], "rxcui": ["2706338", "2706345"], "spl_set_id": ["1fa1aa80-1c59-44d4-9841-b6c52882651b"], "pharm_class_epc": ["Complement Inhibitor [EPC]"], "pharm_class_moa": ["Complement Inhibitors [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (51759-208-13)  / 30 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51759-208-13", "marketing_start_date": "20250407"}], "brand_name": "EPYSQLI", "product_id": "51759-208_d3bb3a53-96c5-43e2-aba5-c5c971149741", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Complement Inhibitor [EPC]", "Complement Inhibitors [MoA]"], "product_ndc": "51759-208", "generic_name": "Eculizumab-aagh", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPYSQLI", "active_ingredients": [{"name": "ECULIZUMAB", "strength": "300 mg/30mL"}], "application_number": "BLA761340", "marketing_category": "BLA", "marketing_start_date": "20250407", "listing_expiration_date": "20261231"}