FDA.reportPublic FDA data

Selarsdi

Product NDC
51759-505
11-digit product format
517590505
Labeler code
51759
Product ID
51759-505_640e5a4e-13d5-4c59-8f37-41cd31fa4fc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-aekn
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Teva Pharmaceuticals USA, Inc.
Application
BLA761343
Marketing category
BLA
Marketing start
2025-03-12
Substance
USTEKINUMAB-AEKN
Active strength
45 mg/.5mL
Pharmacologic classes
Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], 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
Selarsdi
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB-AEKN45 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui2705382, 2705389, 2705393, 2705398, 2705400, 2705401, 2726116, 2726118

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
9101c6a6-2dd0-4586-9db6-ccb20dc679c9Product name220171206
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51759-505-13Selarsdi0.5 mL in 1 VIALINJECTION, SOLUTION0.513
51759-505-13Selarsdi1 in 1 CARTONINJECTION, SOLUTION113
51759-505-32Selarsdi1 in 1 TRAYINJECTION, SOLUTION113
51759-505-32Selarsdi1 in 1 CARTONINJECTION, SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51759-505-13ML - Milliliter51759-505b7fb2fa6-49d9-4f6b-85eb-b88f637c6a5b12025-11-13
51759-505-32ML - Milliliter51759-50583c9a7a0-7823-4d4b-8e1f-4e8c1144dd9012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51759-505SELARSDI (USTEKINUMAB-AEKN) INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.]7Current NDC, 4 package rows20250322_87f75b59-e48b-47c7-a4c0-5fe5965660e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705389Selarsdi 130 MG in 26 ML InjectionPSN87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705398Selarsdi 45 MG in 0.5 ML Prefilled SyringePSN87f75b59-e48b-47c7-a4c0-5fe5965660e713
2726118Selarsdi 90 MG/ML in 0.5 ML InjectionPSN87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705401Selarsdi 90 MG/ML in 1 ML Prefilled SyringePSN87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705382ustekinumab-aekn 130 MG in 26 ML InjectionPSN87f75b59-e48b-47c7-a4c0-5fe5965660e713
2726116ustekinumab-aekn 45 MG in 0.5 ML InjectionPSN87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705393ustekinumab-aekn 45 MG in 0.5 ML Prefilled SyringePSN87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705400ustekinumab-aekn 90 MG in 1 ML Prefilled SyringePSN87f75b59-e48b-47c7-a4c0-5fe5965660e713
27261180.5 ML ustekinumab-aekn 90 MG/ML Injection [Selarsdi]SBD87f75b59-e48b-47c7-a4c0-5fe5965660e713
27053980.5 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe [Selarsdi]SBD87f75b59-e48b-47c7-a4c0-5fe5965660e713
27054011 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe [Selarsdi]SBD87f75b59-e48b-47c7-a4c0-5fe5965660e713
270538926 ML ustekinumab-aekn 5 MG/ML Injection [Selarsdi]SBD87f75b59-e48b-47c7-a4c0-5fe5965660e713
27261160.5 ML ustekinumab-aekn 90 MG/ML InjectionSCD87f75b59-e48b-47c7-a4c0-5fe5965660e713
27053930.5 ML ustekinumab-aekn 90 MG/ML Prefilled SyringeSCD87f75b59-e48b-47c7-a4c0-5fe5965660e713
27054001 ML ustekinumab-aekn 90 MG/ML Prefilled SyringeSCD87f75b59-e48b-47c7-a4c0-5fe5965660e713
270538226 ML ustekinumab-aekn 5 MG/ML InjectionSCD87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705389Selarsdi 130 MG per 26 ML InjectionSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2726118Selarsdi 45 MG per 0.5 ML InjectionSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705398Selarsdi 45 MG per 0.5 ML Prefilled SyringeSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705389Selarsdi 5 MG/ML per 26 ML InjectionSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705401Selarsdi 90 MG per 1 ML Prefilled SyringeSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2726118Selarsdi 90 MG/ML per 0.5 ML InjectionSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705398Selarsdi 90 MG/ML per 0.5 ML Prefilled SyringeSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705401Selarsdi 90 MG/ML per 1 ML Prefilled SyringeSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705382ustekinumab-aekn 130 MG per 26 ML InjectionSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2726116ustekinumab-aekn 45 MG per 0.5 ML InjectionSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705393ustekinumab-aekn 45 MG per 0.5 ML Prefilled SyringeSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705382ustekinumab-aekn 5 MG/ML per 26 ML InjectionSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705400ustekinumab-aekn 90 MG per 1 ML Prefilled SyringeSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2726116ustekinumab-aekn 90 MG/ML per 0.5 ML InjectionSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705393ustekinumab-aekn 90 MG/ML per 0.5 ML Prefilled SyringeSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705400ustekinumab-aekn 90 MG/ML per 1 ML Prefilled SyringeSY87f75b59-e48b-47c7-a4c0-5fe5965660e713
2705393ustekinumab-aekn 45 MG in 0.5 ML Prefilled SyringePSN052a3fb2-21c3-4c4e-a01e-afdd1accd1cd6
2705400ustekinumab-aekn 90 MG in 1 ML Prefilled SyringePSN052a3fb2-21c3-4c4e-a01e-afdd1accd1cd6
27053930.5 ML ustekinumab-aekn 90 MG/ML Prefilled SyringeSCD052a3fb2-21c3-4c4e-a01e-afdd1accd1cd6
27054001 ML ustekinumab-aekn 90 MG/ML Prefilled SyringeSCD052a3fb2-21c3-4c4e-a01e-afdd1accd1cd6
2705393ustekinumab-aekn 45 MG per 0.5 ML Prefilled SyringeSY052a3fb2-21c3-4c4e-a01e-afdd1accd1cd6
2705400ustekinumab-aekn 90 MG per 1 ML Prefilled SyringeSY052a3fb2-21c3-4c4e-a01e-afdd1accd1cd6
2705393ustekinumab-aekn 90 MG/ML per 0.5 ML Prefilled SyringeSY052a3fb2-21c3-4c4e-a01e-afdd1accd1cd6
2705400ustekinumab-aekn 90 MG/ML per 1 ML Prefilled SyringeSY052a3fb2-21c3-4c4e-a01e-afdd1accd1cd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51759-505-13517590505131 VIAL in 1 CARTON (51759-505-13) / .5 mL in 1 VIAL1 vial2025-10-16NoNoHistorical
51759-505-32517590505321 TRAY in 1 CARTON (51759-505-32) / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS1 tray2025-03-12NoNoHistorical