zilbrysq

Generic: zilucoplan

Labeler: ucb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zilbrysq
Generic Name zilucoplan
Labeler ucb, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

zilucoplan 40 mg/mL

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-992
Product ID 50474-992_49eeeabf-4c62-63cb-e063-6394a90a8248
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216834
Listing Expiration 2027-12-31
Marketing Start 2024-01-03

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 50474992
Hyphenated Format 50474-992

Supplemental Identifiers

RxCUI
2672496 2672502 2672504 2672505 2672506 2672507
UNII
YG391PK0CC
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 zilbrysq (source: ndc)
Generic Name zilucoplan (source: ndc)
Application Number NDA216834 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 4 CARTON in 1 BOX (50474-992-80) / 7 SYRINGE, GLASS in 1 CARTON / .81 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

50474-992-80 4 CARTON in 1 BOX (50474-992-80) / 7 SYRINGE, GLASS in 1 CARTON / .81 mL in 1 SYRINGE, GLASS

Ingredients (1)

zilucoplan (40 mg/mL)

Linked Drug Pages (1)

ZILBRYSQ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "49eeeabf-4c62-63cb-e063-6394a90a8248", "openfda": {"nui": ["N0000175575", "N0000175974"], "unii": ["YG391PK0CC"], "rxcui": ["2672496", "2672502", "2672504", "2672505", "2672506", "2672507"], "spl_set_id": ["9f1d53d6-e495-4a3a-8bb9-680a15d25034"], "pharm_class_epc": ["Complement Inhibitor [EPC]"], "pharm_class_moa": ["Complement Inhibitors [MoA]"], "manufacturer_name": ["UCB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 CARTON in 1 BOX (50474-992-80)  / 7 SYRINGE, GLASS in 1 CARTON / .81 mL in 1 SYRINGE, GLASS", "package_ndc": "50474-992-80", "marketing_start_date": "20240103"}], "brand_name": "ZILBRYSQ", "product_id": "50474-992_49eeeabf-4c62-63cb-e063-6394a90a8248", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Complement Inhibitor [EPC]", "Complement Inhibitors [MoA]"], "product_ndc": "50474-992", "generic_name": "zilucoplan", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZILBRYSQ", "active_ingredients": [{"name": "ZILUCOPLAN", "strength": "40 mg/mL"}], "application_number": "NDA216834", "marketing_category": "NDA", "marketing_start_date": "20240103", "listing_expiration_date": "20271231"}