Home NDC 57894-421 SYLVANT
Product NDC 57894-421
11-digit product format 578940421
Labeler code 57894
Product ID 57894-421_7c319292-67e4-11e9-a1df-32bf0099106d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name siltuximab
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Janssen Biotech, Inc.
Application BLA125496
Marketing category BLA
Marketing start 2014-04-01
Marketing end 2021-01-31
Substance SILTUXIMAB
Active strength 400 mg/1
Pharmacologic classes Interleukin-6 Antagonist [EPC],Interleukin-6 Antagonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 57894-421-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 57894-421-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 57894-421-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 57894-421-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 57894-421-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 57894-421-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57894-421-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57894-421-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57894-421-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 57894-421-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 57894-421-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57894-421-01 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded siltuximab ACTIVE INGREDIENT T4H8FMA7IM SYLVANT (SILTUXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.] 5 siltuximab ACTIVE MOIETY T4H8FMA7IM SYLVANT (SILTUXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.] 5 histidine INACTIVE INGREDIENT 4QD397987E SYLVANT (SILTUXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.] 5 histidine monohydrochloride monohydrate INACTIVE INGREDIENT X573657P6P SYLVANT (SILTUXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.] 5 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H SYLVANT (SILTUXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.] 5 sucrose INACTIVE INGREDIENT C151H8M554 SYLVANT (SILTUXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN BIOTECH, INC.] 5
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sylvant SILTUXIMAB Recordati Rare Diseases, Inc. 8d663642-f52e-49c0-a023-2da083fdfc0b 2024-08-27 Warnings, Adverse reactions Exact identifier application number: BLA125496
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125496 Sylvant siltuximab 351(a) Rx 2026-06-01