NDC 47335-177

ILUMYA

Tildrakizumab-asmn

ILUMYA is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Tildrakizumab.

• Product ID: 47335-177_38b1fe34-2474-48a6-8d80-ce4abdaed9d6
• NDC: 47335-177
• Product Type: Human Prescription Drug
• Proprietary Name: ILUMYA
• Generic Name: Tildrakizumab-asmn
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-08-06
• Marketing Category: BLA / BLA
• Application Number: BLA761067
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: TILDRAKIZUMAB
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Interleukin-23 Antagonist [EPC],Interleukin-23 Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 47335-177-01

1 mL in 1 SYRINGE, GLASS (47335-177-01)

• Marketing Start Date: 2018-08-06
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 47335-177-01 [47335017701]

ILUMYA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761067
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-06

NDC 47335-177-95 [47335017795]

ILUMYA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761067
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-08-06

NDC 47335-177-96 [47335017796]

ILUMYA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761067
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-06

NDC 47335-177-10 [47335017710]

ILUMYA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761067
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-06

Drug Details

Active Ingredients

Ingredient	Strength
TILDRAKIZUMAB	100 mg/mL

OpenFDA Data

• SPL SET ID: c6a322bb-51b9-4f0e-8642-62a9682ffcde
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • DEW6X41BEK
• RxNorm Concept Unique ID - RxCUI:
  • 2053453
  • 2053458

Pharmacological Class

• Interleukin-23 Antagonist [EPC]
• Interleukin-23 Antagonists [MoA]