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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TILDRAKIZUMAB100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDEW6X41BEK
Rxcui2053453, 2053458

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99d9fe2d-9c63-4f9f-8249-610666d7e123Product name120230809
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-177-01ILUMYA1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION118
47335-177-10ILUMYA1 mL in 1 CARTONINJECTION, SOLUTION118
47335-177-95ILUMYA1 mL in 1 CARTONINJECTION, SOLUTION118
47335-177-96ILUMYA1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-177ILUMYA (TILDRAKIZUMAB-ASMN) INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]17Current NDC, Legacy NDC, 4 package rows20250227_c6a322bb-51b9-4f0e-8642-62a9682ffcde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2053458ILUMYA 100 MG in 1 ML Prefilled SyringePSNc6a322bb-51b9-4f0e-8642-62a9682ffcde18
2053453tildrakizumab-asmn 100 MG in 1 ML Prefilled SyringePSNc6a322bb-51b9-4f0e-8642-62a9682ffcde18
20534581 ML tildrakizumab-asmn 100 MG/ML Prefilled Syringe [Ilumya]SBDc6a322bb-51b9-4f0e-8642-62a9682ffcde18
20534531 ML tildrakizumab-asmn 100 MG/ML Prefilled SyringeSCDc6a322bb-51b9-4f0e-8642-62a9682ffcde18
20534581 ML Ilumya 100 MG/ML Prefilled SyringeSYc6a322bb-51b9-4f0e-8642-62a9682ffcde18
2053458Ilumya 100 MG per 1 ML Prefilled SyringeSYc6a322bb-51b9-4f0e-8642-62a9682ffcde18
2053453tildrakizumab-asmn 100 MG per 1 ML Prefilled SyringeSYc6a322bb-51b9-4f0e-8642-62a9682ffcde18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-177-01473350177011 mL in 1 SYRINGE, GLASS (47335-177-01) 1 ml2018-08-060000-00-00YesNoCurrent
47335-177-10473350177101 mL in 1 CARTON (47335-177-10) 1 ml2018-08-060000-00-00YesNoCurrent
47335-177-95473350177951 mL in 1 CARTON (47335-177-95) 1 ml2018-08-060000-00-00NoNoCurrent
47335-177-96473350177961 mL in 1 SYRINGE, GLASS (47335-177-96) 1 ml2018-08-060000-00-00NoNoCurrent