FDA.reportPublic FDA data

SELARSDI

Product NDC
50090-7769
11-digit product format
500907769
Labeler code
50090
Product ID
50090-7769_81578a89-3268-4b46-8cf7-79af3145f247
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-aekn
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA761343
Marketing category
BLA
Marketing start
2025-03-12
Substance
USTEKINUMAB
Active strength
90 mg/mL
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
USTEKINUMAB90 mg/mL

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
2705400Internal RxNorm lookup
2705401Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3b483f4-3426-4d6d-97ae-39848ec1bfaeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
50090-7769-0SELARSDI1 in 1 CARTONINJECTION, SOLUTION11
50090-7769-0SELARSDI1 mL in 1 TRAYINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7769-0ML - Milliliter50090-7769bf6fda05-ccf9-49eb-bfdc-0ba3a0b15b3d12026-01-08

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
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
ndc (product): 50090-7769

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
2705401Selarsdi 90 MG/ML in 1 ML Prefilled SyringePSNb3b483f4-3426-4d6d-97ae-39848ec1bfae1
2705400ustekinumab-aekn 90 MG in 1 ML Prefilled SyringePSNb3b483f4-3426-4d6d-97ae-39848ec1bfae1
27054011 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe [Selarsdi]SBDb3b483f4-3426-4d6d-97ae-39848ec1bfae1
27054001 ML ustekinumab-aekn 90 MG/ML Prefilled SyringeSCDb3b483f4-3426-4d6d-97ae-39848ec1bfae1
2705401Selarsdi 90 MG per 1 ML Prefilled SyringeSYb3b483f4-3426-4d6d-97ae-39848ec1bfae1
2705401Selarsdi 90 MG/ML per 1 ML Prefilled SyringeSYb3b483f4-3426-4d6d-97ae-39848ec1bfae1
2705400ustekinumab-aekn 90 MG per 1 ML Prefilled SyringeSYb3b483f4-3426-4d6d-97ae-39848ec1bfae1
2705400ustekinumab-aekn 90 MG/ML per 1 ML Prefilled SyringeSYb3b483f4-3426-4d6d-97ae-39848ec1bfae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7769-0500907769001 TRAY in 1 CARTON (50090-7769-0) / 1 mL in 1 TRAY1 tray2025-11-17NoNoCurrent