NDC 57894-420

SYLVANT

Siltuximab

SYLVANT is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Siltuximab.

• Product ID: 57894-420_62686022-7ea4-11e8-8599-a18b9d46d017
• NDC: 57894-420
• Product Type: Human Prescription Drug
• Proprietary Name: SYLVANT
• Generic Name: Siltuximab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-04-23
• Marketing Category: BLA / BLA
• Application Number: BLA125496
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: SILTUXIMAB
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Interleukin-6 Antagonist [EPC],Interleukin-6 Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 57894-420-01

1 VIAL, SINGLE-USE in 1 CARTON (57894-420-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2014-04-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57894-420-01 [57894042001]

SYLVANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125496
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-23
• Marketing End Date: 2021-01-31

Drug Details

Active Ingredients

Ingredient	Strength
SILTUXIMAB	100 mg/1

OpenFDA Data

• SPL SET ID: 451f535b-8b6b-4ecf-9f19-d921b72eea39
• Manufacturer:
  • Janssen Biotech, Inc.
• UNII:
  • T4H8FMA7IM
• RxNorm Concept Unique ID - RxCUI:
  • 1658139
  • 1658141
  • 1658132
  • 1658135

Pharmacological Class

• Interleukin-6 Antagonist [EPC]
• Interleukin-6 Antagonists [MoA]

NDC Crossover Matching brand name "SYLVANT" or generic name "Siltuximab"

NDC	Brand Name	Generic Name
57894-420	SYLVANT	siltuximab
57894-421	SYLVANT	siltuximab
73090-420	Sylvant	Siltuximab
73090-421	Sylvant	Siltuximab