FDA.reportPublic FDA data

STEQEYMA

Product NDC
72606-029
11-digit product format
726060029
Labeler code
72606
Product ID
72606-029_41fbe62e-a448-4c10-89fb-197959983091
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-stba
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
CELLTRION USA, Inc.
Application
BLA761338
Marketing category
BLA
Marketing start
2025-03-12
Substance
USTEKINUMAB
Active strength
130 mg/26mL
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STEQEYMAUSTEKINUMAB-STBACELLTRION USA, Inc.66085e17-e3f2-4196-8c81-87448e804b0c2026-04-07Warnings, Adverse reactionsExact identifier
application number: BLA761338
ndc (product): 72606-029

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB130 mg/26mL

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
2700393Internal RxNorm lookup
2700400Internal RxNorm lookup
2700404Internal RxNorm lookup
2700409Internal RxNorm lookup
2700411Internal RxNorm lookup
2700412Internal RxNorm lookup
2740798Internal RxNorm lookup
2740800Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
66085e17-e3f2-4196-8c81-87448e804b0cAvailable 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
72606-029-01STEQEYMA1 in 1 CARTONINJECTION, SOLUTION112
72606-029-01STEQEYMA26 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION2612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72606-029-01ML - Milliliter72606-029253a6644-6df5-406c-b3c9-2b6ce2c5544212025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-029STEQEYMA (USTEKINUMAB-STBA) INJECTION, SOLUTION [CELLTRION USA INC.]6Current NDC, 2 package rows20250422_66085e17-e3f2-4196-8c81-87448e804b0c.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761338Steqeymaustekinumab-stba351(k) InterchangeableRx2026-06-01

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 formatDescriptionMarketing startSampleExclude flagStatus
72606-029-01726060029011 VIAL, SINGLE-USE in 1 CARTON (72606-029-01) / 26 mL in 1 VIAL, SINGLE-USE2025-03-12NoNoCurrent