NDC 57894-160

INFLIXIMAB

Infliximab

INFLIXIMAB 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 ID57894-160_5b95c131-42b2-4cda-bd00-101b93199f95
NDC57894-160
Product TypeHuman Prescription Drug
Proprietary NameINFLIXIMAB
Generic NameInfliximab
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-10-05
Marketing CategoryBLA /
Application NumberBLA103772
Labeler NameJanssen Biotech, Inc.
Substance NameINFLIXIMAB
Active Ingredient Strength100 mg/10mL
Pharm ClassesTumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 57894-160-01

1 VIAL, SINGLE-USE in 1 BOX (57894-160-01) > 10 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2021-10-05
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
57894-160INFLIXIMABINFLIXIMAB
57894-030REMICADEINFLIXIMAB
0006-4305Renflexisinfliximab
78206-162Renflexisinfliximab

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