FDA.reportPublic FDA data

Ustekinumab-aekn

Product NDC
51759-413
11-digit product format
517590413
Labeler code
51759
Product ID
51759-413_ce170247-5614-44bc-88e0-89f515d9d8be
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
2025-12-23
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
2027-12-31
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
ndc (product): 51759-413
SelarsdiUSTEKINUMAB-AEKNTeva Pharmaceuticals USA, Inc.87f75b59-e48b-47c7-a4c0-5fe5965660e72026-06-24Warnings, Adverse reactionsExact identifier
application number: BLA761343
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
Ustekinumab-aekn
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2705393Internal RxNorm lookup
2705400Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
052a3fb2-21c3-4c4e-a01e-afdd1accd1cdAvailable 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
51759-413-32Ustekinumab-aekn1 in 1 CARTONINJECTION, SOLUTION16
51759-413-32Ustekinumab-aekn1 in 1 TRAYINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51759-413-32ML - Milliliter51759-4132637168a-6cff-4f03-82c3-83f6319a778212026-01-08

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
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
51759-413-32517590413321 TRAY in 1 CARTON (51759-413-32) / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS1 tray2025-12-23NoNoCurrent