FDA.reportPublic FDA data

Sylvant

Product NDC
73090-421
11-digit product format
730900421
Labeler code
73090
Product ID
73090-421_c32bb83e-f9f4-4a6e-928a-f736138996b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Siltuximab
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Recordati Rare Diseases, Inc.
Application
BLA125496
Marketing category
BLA
Marketing start
2014-04-23
Substance
SILTUXIMAB
Active strength
400 mg/1
Pharmacologic classes
Interleukin-6 Antagonist [EPC], Interleukin-6 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sylvant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILTUXIMAB400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T4H8FMA7IMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1658132Internal RxNorm lookup
1658135Internal RxNorm lookup
1658139Internal RxNorm lookup
1658141Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d663642-f52e-49c0-a023-2da083fdfc0bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73090-421-012024-02-14C16284748780-11030e365-4697-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SYLVANT ® safely and effectively. See full prescribing information for SYLVANT. SYLVANT (siltuximab) for injection, for intravenous use Initial U.S. Approval: 2014
73090-421-012024-01-30C16284748780-11030e365-4697-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SYLVANT ® safely and effectively. See full prescribing information for SYLVANT. SYLVANT (siltuximab) for injection, for intravenous use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73090-421-01Sylvant1 in 1 BOXINJECTION, POWDER, FOR SOLUTION17
73090-421-01Sylvant1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73090-421-01EA - Each73090-42102041b58-4abb-4006-a354-bc69ad0d8e0212021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73090-421SYLVANT (SILTUXIMAB) INJECTION, POWDER, FOR SOLUTION [RECORDATI RARE DISEASES, INC.]7Current NDC, Legacy NDC, 2 package rows20240829_8d663642-f52e-49c0-a023-2da083fdfc0b.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
SylvantSILTUXIMABRecordati Rare Diseases, Inc.8d663642-f52e-49c0-a023-2da083fdfc0b2024-08-27Warnings, Adverse reactionsExact identifier
application number: BLA125496
ndc (product): 73090-421

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125496Sylvantsiltuximab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658132siltuximab 100 MG InjectionPSN8d663642-f52e-49c0-a023-2da083fdfc0b7
1658139siltuximab 400 MG InjectionPSN8d663642-f52e-49c0-a023-2da083fdfc0b7
1658135Sylvant 100 MG InjectionPSN8d663642-f52e-49c0-a023-2da083fdfc0b7
1658141Sylvant 400 MG InjectionPSN8d663642-f52e-49c0-a023-2da083fdfc0b7
1658135siltuximab 100 MG Injection [Sylvant]SBD8d663642-f52e-49c0-a023-2da083fdfc0b7
1658141siltuximab 400 MG Injection [Sylvant]SBD8d663642-f52e-49c0-a023-2da083fdfc0b7
1658132siltuximab 100 MG InjectionSCD8d663642-f52e-49c0-a023-2da083fdfc0b7
1658139siltuximab 400 MG InjectionSCD8d663642-f52e-49c0-a023-2da083fdfc0b7
1658135Sylvant 100 MG InjectionSY8d663642-f52e-49c0-a023-2da083fdfc0b7
1658141Sylvant 400 MG InjectionSY8d663642-f52e-49c0-a023-2da083fdfc0b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73090-421-01730900421011 VIAL, SINGLE-DOSE in 1 BOX (73090-421-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2014-04-230000-00-00NoNoCurrent