FDA.reportPublic FDA data

TREMFYA

Product NDC
57894-650
11-digit product format
578940650
Labeler code
57894
Product ID
57894-650_ebe07a22-1b8b-4403-99dc-e7f34308d5d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guselkumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Janssen Biotech, Inc.
Application
BLA761061
Marketing category
BLA
Marketing start
2024-09-11
Substance
GUSELKUMAB
Active strength
200 mg/20mL
Pharmacologic classes
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
TREMFYA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUSELKUMAB200 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
089658A12DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1928686Internal RxNorm lookup
1928689Internal RxNorm lookup
2118739Internal RxNorm lookup
2118741Internal RxNorm lookup
2693088Internal RxNorm lookup
2693092Internal RxNorm lookup
2693094Internal RxNorm lookup
2693095Internal RxNorm lookup
2693096Internal RxNorm lookup
2693097Internal RxNorm lookup
2711637Internal RxNorm lookup
2711638Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
32f71a4d-ecdf-47e6-a4d4-be46f5f415ddProduct name220250325
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57894-650-01TREMFYA20 mL in 1 VIAL, SINGLE-DOSEINJECTION2028
57894-650-02TREMFYA1 in 1 CARTONINJECTION128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-650-01ML - Milliliter57894-650469a3582-ad0d-4602-b301-56b37106bdd112024-10-04
57894-650-02ML - Milliliter57894-650213ab915-17fd-4a14-8a93-59e3f34940bf12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-650TREMFYA (GUSELKUMAB) INJECTION TREMFYA (GUSELKUMAB) INJECTION [JANSSEN BIOTECH, INC.]20Current NDC, 2 package rows20250519_1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56.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
TREMFYAGUSELKUMABJanssen Biotech, Inc.1e6dc9ae-1c4c-42d9-87aa-c315ecc51b562026-06-04Warnings, Adverse reactionsExact identifier
application number: BLA761061
ndc (product): 57894-650

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761061Tremfyaguselkumab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2711638{2 (2 ML guselkumab 100 MG/ML Auto-Injector [Tremfya]) } Pack [Tremfya Induction Pack for Crohn's Disease]BPCK1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2711637{2 (2 ML guselkumab 100 MG/ML Auto-Injector) } PackGPCK1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2118739guselkumab 100 MG in 1 ML Auto-InjectorPSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
1928686guselkumab 100 MG in 1 ML Prefilled SyringePSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693094guselkumab 200 MG in 2 ML Auto-InjectorPSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693096guselkumab 200 MG in 2 ML Prefilled SyringePSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693088guselkumab 200 MG in 20 ML InjectionPSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2711637guselkumab Induction Pack for Crohn's Disease (2 count)PSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2118741Tremfya 100 MG in 1 ML Auto-InjectorPSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
1928689Tremfya 100 MG in 1 ML Prefilled SyringePSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693095Tremfya 200 MG in 2 ML Auto-InjectorPSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693097Tremfya 200 MG in 2 ML Prefilled SyringePSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693092Tremfya 200 MG in 20 ML InjectionPSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2711638Tremfya Induction Pack for Crohn's DiseasePSN1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
21187411 ML guselkumab 100 MG/ML Auto-Injector [Tremfya]SBD1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
19286891 ML guselkumab 100 MG/ML Prefilled Syringe [Tremfya]SBD1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
26930952 ML guselkumab 100 MG/ML Auto-Injector [Tremfya]SBD1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
26930972 ML guselkumab 100 MG/ML Prefilled Syringe [Tremfya]SBD1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
269309220 ML guselkumab 10 MG/ML Injection [Tremfya]SBD1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
21187391 ML guselkumab 100 MG/ML Auto-InjectorSCD1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
19286861 ML guselkumab 100 MG/ML Prefilled SyringeSCD1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
26930942 ML guselkumab 100 MG/ML Auto-InjectorSCD1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
26930962 ML guselkumab 100 MG/ML Prefilled SyringeSCD1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
269308820 ML guselkumab 10 MG/ML InjectionSCD1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
21187411 ML Tremfya 100 MG/ML Auto-InjectorSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
19286891 ML Tremfya 100 MG/ML Prefilled SyringeSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
1928686guselkumab 100 MG in 1 ML Prefilled SyringeSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2118739guselkumab 100 MG per 1 ML Auto-InjectorSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693094guselkumab 200 MG per 2 ML Auto-InjectorSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693096guselkumab 200 MG per 2 ML Prefilled SyringeSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693088guselkumab 200 MG per 20 ML InjectionSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2711637guselkumab Induction Pack for Crohn's Disease (2 count)SY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2118741Tremfya 100 MG per 1 ML Auto-InjectorSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693095Tremfya 200 MG per 2 ML Auto-InjectorSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693097Tremfya 200 MG per 2 ML Prefilled SyringeSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2693092Tremfya 200 MG per 20 ML InjectionSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628
2711638Tremfya Induction Pack for Crohn's DiseaseSY1e6dc9ae-1c4c-42d9-87aa-c315ecc51b5628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57894-650-015789406500120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
57894-650-02578940650021 VIAL, SINGLE-DOSE in 1 CARTON (57894-650-02) / 20 mL in 1 VIAL, SINGLE-DOSE (57894-650-01) 2024-09-11NoNoCurrent