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 Identifiers#

Field, Values table
FieldValues
UniiT4H8FMA7IM
Rxcui1658132, 1658135, 1658139, 1658141

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

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