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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ustekinumab-aeknUSTEKINUMAB-AEKNTeva Pharmaceuticals USA, Inc.183a1dff-ef33-4ddb-ba38-f7861b0f77ad2026-07-30Warnings, Adverse reactionsExact identifier
application number: BLA761343
Ustekinumab-aeknUSTEKINUMAB-AEKNTeva Pharmaceuticals USA, Inc.052a3fb2-21c3-4c4e-a01e-afdd1accd1cd2026-07-24Warnings, Adverse reactionsExact identifier
application number: BLA761343
SelarsdiUSTEKINUMAB-AEKNTeva Pharmaceuticals USA, Inc.87f75b59-e48b-47c7-a4c0-5fe5965660e72026-06-24Warnings, Adverse reactionsExact identifier
application number: BLA761343
ndc (product): 51759-505
SELARSDIUSTEKINUMAB-AEKNA-S Medication Solutionsb3b483f4-3426-4d6d-97ae-39848ec1bfae2025-11-20Warnings, Adverse reactionsExact identifier
application number: BLA761343

Additional Listing Data#

Finished product
Yes
Brand name base
Selarsdi
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FU77B4U5Z0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2705382Internal RxNorm lookup
2705389Internal RxNorm lookup
2705393Internal RxNorm lookup
2705398Internal RxNorm lookup
2705400Internal RxNorm lookup
2705401Internal RxNorm lookup
2726116Internal RxNorm lookup
2726118Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
87f75b59-e48b-47c7-a4c0-5fe5965660e7Available on FDA.report

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761343Selarsdiustekinumab-aekn351(k) InterchangeableRx2026-06-01

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 vial2025-10-16NoNoCurrent
51759-505-32517590505321 TRAY in 1 CARTON (51759-505-32) / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS1 tray2025-03-12NoNoCurrent