NDC 57894-030

REMICADE

Infliximab

REMICADE is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Infliximab.

• Product ID: 57894-030_3feed24c-bc48-11e8-b206-ddff66e1f745
• NDC: 57894-030
• Product Type: Human Prescription Drug
• Proprietary Name: REMICADE
• Generic Name: Infliximab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1998-08-24
• Marketing Category: BLA / BLA
• Application Number: BLA103772
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: INFLIXIMAB
• Active Ingredient Strength: 100 mg/10mL
• 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 57894-030-01

1 VIAL, SINGLE-USE in 1 BOX (57894-030-01) > 10 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 1998-08-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57894-030-01 [57894003001]

REMICADE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103772
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-08-24

Drug Details

Active Ingredients

Ingredient	Strength
INFLIXIMAB	100 mg/10mL

OpenFDA Data

• SPL SET ID: a0a046c1-056d-45a9-bfd9-13b47c24f257
• Manufacturer:
  • Janssen Biotech, Inc.
• UNII:
  • B72HH48FLU
• RxNorm Concept Unique ID - RxCUI:
  • 213361
  • 310994

Pharmacological Class

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

Medicade Reported Pricing

57894003001 REMICADE 100 MG VIAL

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "REMICADE" or generic name "Infliximab"

NDC	Brand Name	Generic Name
57894-030	REMICADE	INFLIXIMAB
57894-160	INFLIXIMAB	INFLIXIMAB
0006-4305	Renflexis	infliximab
78206-162	Renflexis	infliximab