NDC 57894-071

Simponi

Golimumab

Simponi is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Golimumab.

• Product ID: 57894-071_19ce6e44-67ea-11e9-a359-5dd70099106d
• NDC: 57894-071
• Product Type: Human Prescription Drug
• Proprietary Name: Simponi
• Generic Name: Golimumab
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2013-05-15
• Marketing Category: BLA / BLA
• Application Number: BLA125289
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: GOLIMUMAB
• Active Ingredient Strength: 100 mg/mL
• 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 57894-071-01

1 SYRINGE, GLASS in 1 CARTON (57894-071-01) > 1 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2013-05-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57894-071-01 [57894007101]

Simponi INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125289
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-05-15

NDC 57894-071-02 [57894007102]

Simponi INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125289
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-05-15

NDC 57894-071-90 [57894007190]

Simponi INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125289
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-05-15

NDC 57894-071-89 [57894007189]

Simponi INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125289
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-05-15

Drug Details

Active Ingredients

Ingredient	Strength
GOLIMUMAB	100 mg/mL

OpenFDA Data

• SPL SET ID: f86cb4a7-c358-4136-ae57-b32bda9bba00
• Manufacturer:
  • Janssen Biotech, Inc.
• UNII:
  • 91X1KLU43E
• RxNorm Concept Unique ID - RxCUI:
  • 1653144
  • 1653142
  • 848164
  • 848160
  • 1482813
  • 1653166
  • 1653165
  • 1482814

Pharmacological Class

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

NDC Crossover Matching brand name "Simponi" or generic name "Golimumab"

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