simponi aria

Generic: golimumab

Labeler: janssen biotech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name simponi aria
Generic Name golimumab
Labeler janssen biotech, inc.
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

golimumab 50 mg/4mL

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-350
Product ID 57894-350_3e5ed294-188e-d226-e063-6394a90a5326
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125433
Listing Expiration 2026-12-31
Marketing Start 2013-07-19

Pharmacologic Class

Established (EPC)
tumor necrosis factor blocker [epc]
Mechanism of Action
tumor necrosis factor receptor blocking activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894350
Hyphenated Format 57894-350

Supplemental Identifiers

RxCUI
1431642 1431647
UNII
91X1KLU43E
NUI
N0000175610 N0000175451

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name simponi aria (source: ndc)
Generic Name golimumab (source: ndc)
Application Number BLA125433 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/4mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-01) / 4 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-89) / 4 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

57894-350-01 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-01) / 4 mL in 1 VIAL, SINGLE-DOSE 57894-350-89 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-89) / 4 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

golimumab (50 mg/4mL)

Linked Drug Pages (1)

SIMPONI ARIA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3e5ed294-188e-d226-e063-6394a90a5326", "openfda": {"nui": ["N0000175610", "N0000175451"], "unii": ["91X1KLU43E"], "rxcui": ["1431642", "1431647"], "spl_set_id": ["9e260a47-55af-4c92-8d88-a86ccc767fff"], "pharm_class_epc": ["Tumor Necrosis Factor Blocker [EPC]"], "pharm_class_moa": ["Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-01)  / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-350-01", "marketing_start_date": "20130719"}, {"sample": true, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-89)  / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "57894-350-89", "marketing_start_date": "20130719"}], "brand_name": "SIMPONI ARIA", "product_id": "57894-350_3e5ed294-188e-d226-e063-6394a90a5326", "dosage_form": "SOLUTION", "pharm_class": ["Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "57894-350", "generic_name": "golimumab", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMPONI ARIA", "active_ingredients": [{"name": "GOLIMUMAB", "strength": "50 mg/4mL"}], "application_number": "BLA125433", "marketing_category": "BLA", "marketing_start_date": "20130719", "listing_expiration_date": "20261231"}