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 Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui2705400, 2705401

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

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 tray2025-11-17NoNoHistorical