Home NDC 47335-177 ILUMYA
Product NDC 47335-177
11-digit product format 473350177
Labeler code 47335
Product ID 47335-177_7718538c-3c74-4470-9951-cf9634ab2f31
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tildrakizumab-asmn
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application BLA761067
Marketing category BLA
Marketing start 2018-08-06
Substance TILDRAKIZUMAB
Active strength 100 mg/mL
Pharmacologic classes Interleukin-23 Antagonist [EPC], Interleukin-23 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 ILUMYA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TILDRAKIZUMAB 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DEW6X41BEK Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 47335-177-01 ILUMYA 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 18 47335-177-10 ILUMYA 1 mL in 1 CARTON INJECTION, SOLUTION 1 18 47335-177-95 ILUMYA 1 mL in 1 CARTON INJECTION, SOLUTION 1 18 47335-177-96 ILUMYA 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-177 ILUMYA (TILDRAKIZUMAB-ASMN) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 17 Current NDC, Legacy NDC, 4 package rows 20250227_c6a322bb-51b9-4f0e-8642-62a9682ffcde.zip
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 ILUMYA TILDRAKIZUMAB-ASMN Sun Pharmaceutical Industries, Inc. c6a322bb-51b9-4f0e-8642-62a9682ffcde 2026-07-29 Warnings, Adverse reactions Exact identifier application number: BLA761067 ndc (product): 47335-177
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761067 Ilumya tildrakizumab-asmn 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 47335-177-01 47335017701 1 mL in 1 SYRINGE, GLASS (47335-177-01) 1 ml 2018-08-06 0000-00-00 Yes No Current 47335-177-10 47335017710 1 mL in 1 CARTON (47335-177-10) 1 ml 2018-08-06 0000-00-00 Yes No Current 47335-177-95 47335017795 1 mL in 1 CARTON (47335-177-95) 1 ml 2018-08-06 0000-00-00 No No Current 47335-177-96 47335017796 1 mL in 1 SYRINGE, GLASS (47335-177-96) 1 ml 2018-08-06 0000-00-00 No No Current