FDA.reportPublic FDA data

TREMFYA

Product NDC
57894-651
11-digit product format
578940651
Labeler code
57894
Product ID
57894-651_ebe07a22-1b8b-4403-99dc-e7f34308d5d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guselkumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Janssen Biotech, Inc.
Application
BLA761061
Marketing category
BLA
Marketing start
2024-09-11
Substance
GUSELKUMAB
Active strength
200 mg/2mL
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/2mL

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
57894-651-01TREMFYA2 mL in 1 SYRINGEINJECTION228
57894-651-02TREMFYA1 in 1 CARTONINJECTION128
57894-651-04TREMFYA2 in 1 CARTONINJECTION228
57894-651-11TREMFYA2 mL in 1 SYRINGEINJECTION228
57894-651-22TREMFYA1 in 1 CARTONINJECTION128
57894-651-92TREMFYA1 in 1 CARTONINJECTION128
57894-651-99TREMFYA2 mL in 1 SYRINGEINJECTION228

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-651-01ML - Milliliter57894-65199e35eee-d495-4426-b9e6-303fb7ec8ff512024-10-04
57894-651-02ML - Milliliter57894-651748ce452-b95e-4f70-afc0-9bb12b611cd412024-10-04
57894-651-04ML - Milliliter57894-651ec7ba7a9-cb08-42fc-88ad-4f5201fbec5b12025-05-14
57894-651-11ML - Milliliter57894-6513d84fb3a-1137-47ab-ae47-59be30f9727412024-10-04
57894-651-22ML - Milliliter57894-6518880dbcf-3a71-4ac6-8f16-7925ce08e6ec12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-651TREMFYA (GUSELKUMAB) INJECTION TREMFYA (GUSELKUMAB) INJECTION [JANSSEN BIOTECH, INC.]20Current NDC, 7 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
57894-651-01578940651012 mL in 1 SYRINGE2 mlHistorical
57894-651-02578940651021 SYRINGE in 1 CARTON (57894-651-02) / 2 mL in 1 SYRINGE (57894-651-01) 1 syringe2024-09-11NoNoCurrent
57894-651-04578940651042 CARTON in 1 CARTON (57894-651-04) / 1 SYRINGE in 1 CARTON (57894-651-02) / 2 mL in 1 SYRINGE (57894-651-01) 2 carton2025-03-20NoNoCurrent
57894-651-11578940651112 mL in 1 SYRINGE2 mlHistorical
57894-651-22578940651221 SYRINGE in 1 CARTON (57894-651-22) / 2 mL in 1 SYRINGE (57894-651-11) 1 syringe2024-09-11NoNoCurrent
57894-651-92578940651921 SYRINGE in 1 CARTON (57894-651-92) / 2 mL in 1 SYRINGE (57894-651-99) 1 syringe2024-09-11NoNoCurrent
57894-651-99578940651992 mL in 1 SYRINGE2 mlHistorical