sylvant

Generic: siltuximab

Labeler: recordati rare diseases, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name sylvant
Generic Name siltuximab
Labeler recordati rare diseases, inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

siltuximab 400 mg/1

Manufacturer
Recordati Rare Diseases, Inc.

Identifiers & Regulatory

Product NDC 73090-421
Product ID 73090-421_c32bb83e-f9f4-4a6e-928a-f736138996b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125496
Listing Expiration 2026-12-31
Marketing Start 2014-04-23

Pharmacologic Class

Established (EPC)
interleukin-6 antagonist [epc]
Mechanism of Action
interleukin-6 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73090421
Hyphenated Format 73090-421

Supplemental Identifiers

RxCUI
1658132 1658135 1658139 1658141
UNII
T4H8FMA7IM
NUI
N0000191006 N0000191004

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sylvant (source: ndc)
Generic Name siltuximab (source: ndc)
Application Number BLA125496 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BOX (73090-421-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

73090-421-01 1 VIAL, SINGLE-DOSE in 1 BOX (73090-421-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

siltuximab (400 mg/1)

Linked Drug Pages (1)

Sylvant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c32bb83e-f9f4-4a6e-928a-f736138996b6", "openfda": {"nui": ["N0000191006", "N0000191004"], "unii": ["T4H8FMA7IM"], "rxcui": ["1658132", "1658135", "1658139", "1658141"], "spl_set_id": ["8d663642-f52e-49c0-a023-2da083fdfc0b"], "pharm_class_epc": ["Interleukin-6 Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-6 Antagonists [MoA]"], "manufacturer_name": ["Recordati Rare Diseases, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (73090-421-01)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "73090-421-01", "marketing_start_date": "20140423"}], "brand_name": "Sylvant", "product_id": "73090-421_c32bb83e-f9f4-4a6e-928a-f736138996b6", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Interleukin-6 Antagonist [EPC]", "Interleukin-6 Antagonists [MoA]"], "product_ndc": "73090-421", "generic_name": "Siltuximab", "labeler_name": "Recordati Rare Diseases, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sylvant", "active_ingredients": [{"name": "SILTUXIMAB", "strength": "400 mg/1"}], "application_number": "BLA125496", "marketing_category": "BLA", "marketing_start_date": "20140423", "listing_expiration_date": "20261231"}