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 Identifiers#

Field, Values table
FieldValues
Unii089658A12D
Rxcui1928686, 1928689, 2118739, 2118741, 2693088, 2693092, 2693094, 2693095, 2693096, 2693097, 2711637, 2711638

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

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