FDA.reportPublic FDA data

Siliq

Product NDC
0187-0004
11-digit product format
001870004
Labeler code
0187
Product ID
0187-0004_3031adba-5697-4172-8575-9a1d5d7fc04c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brodalumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Bausch Health US LLC
Application
BLA761032
Marketing category
BLA
Marketing start
2017-02-15
Substance
BRODALUMAB
Active strength
210 mg/1
Pharmacologic classes
Antibodies, Monoclonal [CS], Interleukin 17 Receptor A Antagonists [MoA], Interleukin-17 Receptor A Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRODALUMAB210 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ZA31Y954ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1872256Internal RxNorm lookup
1872261Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a550c33-456a-4833-814e-8591aea7c688Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d12e01f-6e13-4252-9c16-dbf106867722Product name120170504

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-0004-00Siliq1 in 1 SYRINGEINJECTION121
0187-0004-02Siliq2 in 1 CARTONINJECTION221
0187-0004-03Siliq2 in 1 CARTONINJECTION221
0187-0004-04Siliq1 in 1 SYRINGEINJECTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-0004-00ML - Milliliter0187-0004bb07ca87-2dd1-469c-b280-f5f2c5f2992a12017-04-05
0187-0004-02ML - Milliliter0187-000499a658c1-def4-4b3e-8aa8-3532f412049812017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-0004SILIQ (BRODALUMAB) INJECTION [BAUSCH HEALTH US LLC]17Current NDC, Legacy NDC, 4 package rows20241109_1a550c33-456a-4833-814e-8591aea7c688.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SiliqBRODALUMABBausch Health US LLC1a550c33-456a-4833-814e-8591aea7c6882026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761032
ndc (product): 0187-0004

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761032Siliqbrodalumab351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1872256brodalumab 210 MG in 1.5 ML Prefilled SyringePSN1a550c33-456a-4833-814e-8591aea7c68822
1872261SILIQ 210 MG in 1.5 ML Prefilled SyringePSN1a550c33-456a-4833-814e-8591aea7c68822
18722611.5 ML brodalumab 140 MG/ML Prefilled Syringe [Siliq]SBD1a550c33-456a-4833-814e-8591aea7c68822
18722561.5 ML brodalumab 140 MG/ML Prefilled SyringeSCD1a550c33-456a-4833-814e-8591aea7c68822
18722611.5 ML Siliq 140 MG/ML Prefilled SyringeSY1a550c33-456a-4833-814e-8591aea7c68822
1872256brodalumab 210 MG per 1.5 ML Prefilled SyringeSY1a550c33-456a-4833-814e-8591aea7c68822
1872261Siliq 210 MG per 1.5 ML Prefilled SyringeSY1a550c33-456a-4833-814e-8591aea7c68822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-0004-00001870004001 in 1 SYRINGEHistorical
0187-0004-02001870004022 SYRINGE in 1 CARTON (0187-0004-02) / 1 INJECTION in 1 SYRINGE (0187-0004-00) 2 syringe2017-02-150000-00-00NoNoCurrent
0187-0004-03001870004032 INJECTION in 1 CARTON (0187-0004-03)2 injection2026-06-011Current
0187-0004-04001870004041 INJECTION in 1 SYRINGE (0187-0004-04)1 injection2026-06-011Current