FDA.reportPublic FDA data

ZILBRYSQ

Product NDC
50474-990
11-digit product format
504740990
Labeler code
50474
Product ID
50474-990_49eeeabf-4c62-63cb-e063-6394a90a8248
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zilucoplan
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
UCB, Inc.
Application
NDA216834
Marketing category
NDA
Marketing start
2024-01-03
Substance
ZILUCOPLAN
Active strength
40 mg/mL
Pharmacologic classes
Complement Inhibitor [EPC], Complement Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZILBRYSQ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZILUCOPLAN40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYG391PK0CC
Rxcui2672496, 2672502, 2672504, 2672505, 2672506, 2672507

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5017567-4b89-47d2-9d4f-3fe2e6641b4dProduct name120250630
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50474-990-80ZILBRYSQ4 in 1 BOXINJECTION, SOLUTION413
50474-990-80ZILBRYSQ7 in 1 CARTONINJECTION, SOLUTION713

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50474-990-80ML - Milliliter50474-9907f769769-124c-407f-8609-441f4b2eba7212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50474-990ZILBRYSQ (ZILUCOPLAN) INJECTION, SOLUTION [UCB, INC.]11Current NDC, 2 package rows20250316_9f1d53d6-e495-4a3a-8bb9-680a15d25034.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672502ZILBRYSQ 16.6 MG in 0.416 ML Prefilled SyringePSN9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672505ZILBRYSQ 23 MG in 0.574 ML Prefilled SyringePSN9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672507ZILBRYSQ 32.4 MG in 0.81 ML Prefilled SyringePSN9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672496zilucoplan 16.6 MG in 0.416 ML Prefilled SyringePSN9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672504zilucoplan 23 MG in 0.574 ML Prefilled SyringePSN9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672506zilucoplan 32.4 MG in 0.81 ML Prefilled SyringePSN9f1d53d6-e495-4a3a-8bb9-680a15d2503413
26725020.416 ML zilucoplan 40 MG/ML Prefilled Syringe [Zilbrysq]SBD9f1d53d6-e495-4a3a-8bb9-680a15d2503413
26725050.574 ML zilucoplan 40 MG/ML Prefilled Syringe [Zilbrysq]SBD9f1d53d6-e495-4a3a-8bb9-680a15d2503413
26725070.81 ML zilucoplan 40 MG/ML Prefilled Syringe [Zilbrysq]SBD9f1d53d6-e495-4a3a-8bb9-680a15d2503413
26724960.416 ML zilucoplan 40 MG/ML Prefilled SyringeSCD9f1d53d6-e495-4a3a-8bb9-680a15d2503413
26725040.574 ML zilucoplan 40 MG/ML Prefilled SyringeSCD9f1d53d6-e495-4a3a-8bb9-680a15d2503413
26725060.81 ML zilucoplan 40 MG/ML Prefilled SyringeSCD9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672502Zilbrysq 16.6 MG (equivalent to zilucoplan sodium 17 MG) per 0.416 ML Prefilled SyringeSY9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672505Zilbrysq 23 MG (equivalent to zilucoplan sodium 23.6 MG) per 0.574 ML Prefilled SyringeSY9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672507Zilbrysq 32.4 MG (equivalent to zilucoplan sodium 33.2 MG) per 0.81 ML Prefilled SyringeSY9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672496zilucoplan 16.6 MG (equivalent to zilucoplan sodium 17 MG) per 0.416 ML Prefilled SyringeSY9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672504zilucoplan 23 MG (equivalent to zilucoplan sodium 23.6 MG) per 0.574 ML Prefilled SyringeSY9f1d53d6-e495-4a3a-8bb9-680a15d2503413
2672506zilucoplan 32.4 MG (equivalent to zilucoplan sodium 33.2 MG) per 0.81 ML Prefilled SyringeSY9f1d53d6-e495-4a3a-8bb9-680a15d2503413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50474-990-80504740990804 CARTON in 1 BOX (50474-990-80) / 7 SYRINGE, GLASS in 1 CARTON / .416 mL in 1 SYRINGE, GLASS4 carton2024-03-15NoNoHistorical