FDA.reportPublic FDA data

SIMPONI ARIA

Product NDC
57894-350
11-digit product format
578940350
Labeler code
57894
Product ID
57894-350_3e5ed294-188e-d226-e063-6394a90a5326
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
golimumab
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Janssen Biotech, Inc.
Application
BLA125433
Marketing category
BLA
Marketing start
2013-07-19
Substance
GOLIMUMAB
Active strength
50 mg/4mL
Pharmacologic classes
Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SIMPONI ARIA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GOLIMUMAB50 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii91X1KLU43E
Rxcui1431642, 1431647

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5200a1f-9e6e-4db2-833c-52d2be9d7bbbProduct name120151112
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57894-350-01SIMPONI ARIA4 mL in 1 VIAL, SINGLE-DOSESOLUTION428
57894-350-01SIMPONI ARIA1 in 1 CARTONSOLUTION128
57894-350-89SIMPONI ARIA1 in 1 CARTONSOLUTION128
57894-350-89SIMPONI ARIA4 mL in 1 VIAL, SINGLE-DOSESOLUTION428

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-350-01ML - Milliliter57894-350c19201a6-c036-41c5-8580-f599a9511c2512013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
golimumabACTIVE INGREDIENT91X1KLU43ESIMPONI ARIA (GOLIMUMAB) SOLUTION [JANSSEN BIOTECH, INC.]6
golimumabACTIVE MOIETY91X1KLU43ESIMPONI ARIA (GOLIMUMAB) SOLUTION [JANSSEN BIOTECH, INC.]6
histidineINACTIVE INGREDIENT4QD397987ESIMPONI ARIA (GOLIMUMAB) SOLUTION [JANSSEN BIOTECH, INC.]6
histidine monohydrochloride monohydrateINACTIVE INGREDIENTX573657P6PSIMPONI ARIA (GOLIMUMAB) SOLUTION [JANSSEN BIOTECH, INC.]6
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HSIMPONI ARIA (GOLIMUMAB) SOLUTION [JANSSEN BIOTECH, INC.]6
sorbitolINACTIVE INGREDIENT506T60A25RSIMPONI ARIA (GOLIMUMAB) SOLUTION [JANSSEN BIOTECH, INC.]6
waterINACTIVE INGREDIENT059QF0KO0RSIMPONI ARIA (GOLIMUMAB) SOLUTION [JANSSEN BIOTECH, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-350SIMPONI ARIA (GOLIMUMAB) SOLUTION [JANSSEN BIOTECH, INC.]26Current NDC, Legacy NDC, 4 package rows20250429_9e260a47-55af-4c92-8d88-a86ccc767fff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1431642golimumab 50 MG in 4 mL InjectionPSN9e260a47-55af-4c92-8d88-a86ccc767fff28
1431647Simponi Aria 50 MG in 4 mL InjectionPSN9e260a47-55af-4c92-8d88-a86ccc767fff28
14316474 ML golimumab 12.5 MG/ML Injection [Simponi]SBD9e260a47-55af-4c92-8d88-a86ccc767fff28
14316424 ML golimumab 12.5 MG/ML InjectionSCD9e260a47-55af-4c92-8d88-a86ccc767fff28
14316474 ML Simponi 12.5 MG/ML InjectionSY9e260a47-55af-4c92-8d88-a86ccc767fff28
1431642golimumab 50 MG per 4 ML InjectionSY9e260a47-55af-4c92-8d88-a86ccc767fff28
1431647Simponi Aria 50 MG per 4 ML InjectionSY9e260a47-55af-4c92-8d88-a86ccc767fff28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57894-350-01578940350011 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-01) / 4 mL in 1 VIAL, SINGLE-DOSE2013-07-190000-00-00NoNoCurrent
57894-350-89578940350891 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-89) / 4 mL in 1 VIAL, SINGLE-DOSE2013-07-190000-00-00YesNoCurrent