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

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

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 · 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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761343Selarsdiustekinumab-aekn351(k) InterchangeableRx2026-07-01

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