FDA.reportPublic FDA data

STEQEYMA

Product NDC
72606-028
11-digit product format
726060028
Labeler code
72606
Product ID
72606-028_41fbe62e-a448-4c10-89fb-197959983091
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-stba
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
CELLTRION USA, Inc.
Application
BLA761338
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
STEQEYMA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB90 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFU77B4U5Z0
Rxcui2700393, 2700400, 2700404, 2700409, 2700411, 2700412, 2740798, 2740800

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
72606-028-01STEQEYMA1 mL in 1 SYRINGEINJECTION, SOLUTION112
72606-028-01STEQEYMA1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72606-028-01ML - Milliliter72606-028ca9e4337-4288-4920-af67-2582b542afd912025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-028STEQEYMA (USTEKINUMAB-STBA) INJECTION, SOLUTION [CELLTRION USA INC.]6Current NDC, 2 package rows20250422_66085e17-e3f2-4196-8c81-87448e804b0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2700400SteQeyma 130 MG in 26 ML InjectionPSN66085e17-e3f2-4196-8c81-87448e804b0c12
2740800SteQeyma 45 MG in 0.5 ML InjectionPSN66085e17-e3f2-4196-8c81-87448e804b0c12
2700409SteQeyma 45 MG in 0.5 ML Prefilled SyringePSN66085e17-e3f2-4196-8c81-87448e804b0c12
2700412SteQeyma 90 MG in 1 ML Prefilled SyringePSN66085e17-e3f2-4196-8c81-87448e804b0c12
2700393ustekinumab-stba 130 MG in 26 ML InjectionPSN66085e17-e3f2-4196-8c81-87448e804b0c12
2740798ustekinumab-stba 45 MG in 0.5 ML InjectionPSN66085e17-e3f2-4196-8c81-87448e804b0c12
2700404ustekinumab-stba 45 MG in 0.5 ML Prefilled SyringePSN66085e17-e3f2-4196-8c81-87448e804b0c12
2700411ustekinumab-stba 90 MG in 1 ML Prefilled SyringePSN66085e17-e3f2-4196-8c81-87448e804b0c12
27408000.5 ML ustekinumab-stba 90 MG/ML Injection [Steqeyma]SBD66085e17-e3f2-4196-8c81-87448e804b0c12
27004090.5 ML ustekinumab-stba 90 MG/ML Prefilled Syringe [Steqeyma]SBD66085e17-e3f2-4196-8c81-87448e804b0c12
27004121 ML ustekinumab-stba 90 MG/ML Prefilled Syringe [Steqeyma]SBD66085e17-e3f2-4196-8c81-87448e804b0c12
270040026 ML ustekinumab-stba 5 MG/ML Injection [Steqeyma]SBD66085e17-e3f2-4196-8c81-87448e804b0c12
27407980.5 ML ustekinumab-stba 90 MG/ML InjectionSCD66085e17-e3f2-4196-8c81-87448e804b0c12
27004040.5 ML ustekinumab-stba 90 MG/ML Prefilled SyringeSCD66085e17-e3f2-4196-8c81-87448e804b0c12
27004111 ML ustekinumab-stba 90 MG/ML Prefilled SyringeSCD66085e17-e3f2-4196-8c81-87448e804b0c12
270039326 ML ustekinumab-stba 5 MG/ML InjectionSCD66085e17-e3f2-4196-8c81-87448e804b0c12
2700400Steqeyma 130 MG per 26 ML InjectionSY66085e17-e3f2-4196-8c81-87448e804b0c12
2740800Steqeyma 45 MG per 0.5 ML InjectionSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700409Steqeyma 45 MG per 0.5 ML Prefilled SyringeSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700400Steqeyma 5 MG/ML per 26 ML InjectionSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700412Steqeyma 90 MG per 1 ML Prefilled SyringeSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700409Steqeyma 90 MG/ML per 0.5 ML Prefilled SyringeSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700412Steqeyma 90 MG/ML per 1 ML Prefilled SyringeSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700393ustekinumab-stba 130 MG per 26 ML InjectionSY66085e17-e3f2-4196-8c81-87448e804b0c12
2740798ustekinumab-stba 45 MG per 0.5 ML InjectionSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700404ustekinumab-stba 45 MG per 0.5 ML Prefilled SyringeSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700393ustekinumab-stba 5 MG/ML per 26 ML InjectionSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700411ustekinumab-stba 90 MG per 1 ML Prefilled SyringeSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700404ustekinumab-stba 90 MG/ML per 0.5 ML Prefilled SyringeSY66085e17-e3f2-4196-8c81-87448e804b0c12
2700411ustekinumab-stba 90 MG/ML per 1 ML Prefilled SyringeSY66085e17-e3f2-4196-8c81-87448e804b0c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72606-028-01726060028011 SYRINGE in 1 CARTON (72606-028-01) / 1 mL in 1 SYRINGE1 syringe2025-03-12NoNoHistorical