FDA.reportPublic FDA data

YESINTEK

Product NDC
83257-025
11-digit product format
832570025
Labeler code
83257
Product ID
83257-025_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
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
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
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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2705581Internal RxNorm lookup
2705588Internal RxNorm lookup
2705592Internal RxNorm lookup
2705597Internal RxNorm lookup
2705599Internal RxNorm lookup
2705600Internal RxNorm lookup
2705601Internal RxNorm lookup
2705603Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
12a75613-ee33-d30a-215b-2a51cfa19b00Available 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
83257-025-41YESINTEK1 in 1 CARTONINJECTION, SOLUTION19
83257-025-41YESINTEK1 mL in 1 SYRINGEINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-025-41ML - Milliliter83257-0259aa1cf9a-41a5-41b6-aeb4-dd37d880e4b112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-025YESINTEK (USTEKINUMAB) INJECTION, SOLUTION YESINTEK (USTEKINUMAB) SOLUTION [BIOCON BIOLOGICS INC.]6Current NDC, 2 package rows20250223_12a75613-ee33-d30a-215b-2a51cfa19b00.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YESINTEKUSTEKINUMABBiocon Biologics Inc.12a75613-ee33-d30a-215b-2a51cfa19b002026-03-17Warnings, Adverse reactionsExact identifier
application number: BLA761406
ndc (product): 83257-025

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761406Yesintekustekinumab-kfce351(k) InterchangeableRx2026-07-01

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
83257-025-41832570025411 SYRINGE in 1 CARTON (83257-025-41) / 1 mL in 1 SYRINGE1 syringe2025-02-22NoNoCurrent