NDC 57894-350

SIMPONI ARIA

Golimumab

SIMPONI ARIA is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Golimumab.

• Product ID: 57894-350_2657bdfa-67ea-11e9-9987-91d70099106d
• NDC: 57894-350
• Product Type: Human Prescription Drug
• Proprietary Name: SIMPONI ARIA
• Generic Name: Golimumab
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2013-07-19
• Marketing Category: BLA / BLA
• Application Number: BLA125433
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: GOLIMUMAB
• Active Ingredient Strength: 50 mg/4mL
• Pharm Classes: Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 57894-350-01

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

• Marketing Start Date: 2013-07-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57894-350-89 [57894035089]

SIMPONI ARIA SOLUTION

• Marketing Category: BLA
• Application Number: BLA125433
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-07-19

NDC 57894-350-01 [57894035001]

SIMPONI ARIA SOLUTION

• Marketing Category: BLA
• Application Number: BLA125433
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-07-19

Drug Details

Active Ingredients

Ingredient	Strength
GOLIMUMAB	50 mg/4mL

OpenFDA Data

• SPL SET ID: 9e260a47-55af-4c92-8d88-a86ccc767fff
• Manufacturer:
  • Janssen Biotech, Inc.
• UNII:
  • 91X1KLU43E
• RxNorm Concept Unique ID - RxCUI:
  • 1431647
  • 1431642

Pharmacological Class

• Tumor Necrosis Factor Blocker [EPC]
• Tumor Necrosis Factor Receptor Blocking Activity [MoA]

NDC Crossover Matching brand name "SIMPONI ARIA" or generic name "Golimumab"

NDC	Brand Name	Generic Name
57894-350	SIMPONI ARIA	golimumab
57894-070	Simponi	golimumab
57894-071	Simponi	golimumab