FDA.reportPublic FDA data

YESINTEK

Product NDC
83257-023
11-digit product format
832570023
Labeler code
83257
Product ID
83257-023_c3b2dc18-4456-908e-f957-6bc50d22b925
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Biocon Biologics Inc.
Application
BLA761406
Marketing category
BLA
Marketing start
2025-02-22
Substance
USTEKINUMAB
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
YESINTEK
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB45 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui2705581, 2705588, 2705592, 2705597, 2705599, 2705600, 2705601, 2705603

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
83257-023-41YESINTEK1 in 1 CARTONINJECTION, SOLUTION19
83257-023-41YESINTEK0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-023-41ML - Milliliter83257-023e5d4fe02-717b-4fe6-8880-d2764668f4dd12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-023YESINTEK (USTEKINUMAB) INJECTION, SOLUTION YESINTEK (USTEKINUMAB) SOLUTION [BIOCON BIOLOGICS INC.]6Current NDC, 2 package rows20250223_12a75613-ee33-d30a-215b-2a51cfa19b00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705581ustekinumab-kfce 130 MG in 26 ML InjectionPSN12a75613-ee33-d30a-215b-2a51cfa19b009
2705601ustekinumab-kfce 45 MG in 0.5 ML InjectionPSN12a75613-ee33-d30a-215b-2a51cfa19b009
2705592ustekinumab-kfce 45 MG in 0.5 ML Prefilled SyringePSN12a75613-ee33-d30a-215b-2a51cfa19b009
2705599ustekinumab-kfce 90 MG in 1 ML Prefilled SyringePSN12a75613-ee33-d30a-215b-2a51cfa19b009
2705588Yesintek 130 MG in 26 ML InjectionPSN12a75613-ee33-d30a-215b-2a51cfa19b009
2705603Yesintek 45 MG in 0.5 ML InjectionPSN12a75613-ee33-d30a-215b-2a51cfa19b009
2705597Yesintek 45 MG in 0.5 ML Prefilled SyringePSN12a75613-ee33-d30a-215b-2a51cfa19b009
2705600Yesintek 90 MG in 1 ML Prefilled SyringePSN12a75613-ee33-d30a-215b-2a51cfa19b009
27056030.5 ML ustekinumab-kfce 90 MG/ML Injection [Yesintek]SBD12a75613-ee33-d30a-215b-2a51cfa19b009
27055970.5 ML ustekinumab-kfce 90 MG/ML Prefilled Syringe [Yesintek]SBD12a75613-ee33-d30a-215b-2a51cfa19b009
27056001 ML ustekinumab-kfce 90 MG/ML Prefilled Syringe [Yesintek]SBD12a75613-ee33-d30a-215b-2a51cfa19b009
270558826 ML ustekinumab-kfce 5 MG/ML Injection [Yesintek]SBD12a75613-ee33-d30a-215b-2a51cfa19b009
27056010.5 ML ustekinumab-kfce 90 MG/ML InjectionSCD12a75613-ee33-d30a-215b-2a51cfa19b009
27055920.5 ML ustekinumab-kfce 90 MG/ML Prefilled SyringeSCD12a75613-ee33-d30a-215b-2a51cfa19b009
27055991 ML ustekinumab-kfce 90 MG/ML Prefilled SyringeSCD12a75613-ee33-d30a-215b-2a51cfa19b009
270558126 ML ustekinumab-kfce 5 MG/ML InjectionSCD12a75613-ee33-d30a-215b-2a51cfa19b009
27056030.5 ML Yesintek 90 MG/ML InjectionSY12a75613-ee33-d30a-215b-2a51cfa19b009
27055970.5 ML Yesintek 90 MG/ML Prefilled SyringeSY12a75613-ee33-d30a-215b-2a51cfa19b009
27056001 ML Yesintek 90 MG/ML Prefilled SyringeSY12a75613-ee33-d30a-215b-2a51cfa19b009
270558826 ML Yesintek 5 MG/ML InjectionSY12a75613-ee33-d30a-215b-2a51cfa19b009
2705581ustekinumab-kfce 130 MG per 26 ML InjectionSY12a75613-ee33-d30a-215b-2a51cfa19b009
2705601ustekinumab-kfce 45 MG per 0.5 ML InjectionSY12a75613-ee33-d30a-215b-2a51cfa19b009
2705592ustekinumab-kfce 45 MG per 0.5 ML Prefilled SyringeSY12a75613-ee33-d30a-215b-2a51cfa19b009
2705599ustekinumab-kfce 90 MG per 1 ML Prefilled SyringeSY12a75613-ee33-d30a-215b-2a51cfa19b009
2705588Yesintek 130 MG per 26 ML InjectionSY12a75613-ee33-d30a-215b-2a51cfa19b009
2705603Yesintek 45 MG per 0.5 ML InjectionSY12a75613-ee33-d30a-215b-2a51cfa19b009
2705597Yesintek 45 MG per 0.5 ML Prefilled SyringeSY12a75613-ee33-d30a-215b-2a51cfa19b009
2705600Yesintek 90 MG per 1 ML Prefilled SyringeSY12a75613-ee33-d30a-215b-2a51cfa19b009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83257-023-41832570023411 SYRINGE in 1 CARTON (83257-023-41) / .5 mL in 1 SYRINGE1 syringe2025-02-22YesNoCurrent