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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91X1KLU43EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1431642Internal RxNorm lookup
1431647Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e260a47-55af-4c92-8d88-a86ccc767fffAvailable on FDA.report

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

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
SIMPONI ARIAGOLIMUMABJanssen Biotech, Inc.9e260a47-55af-4c92-8d88-a86ccc767fff2025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125433
ndc (product): 57894-350

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125433Simponi Ariagolimumab351(a)Rx2026-06-01

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