NDC 78206-162

Renflexis

Infliximab

Renflexis is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Organon Llc. The primary component is Infliximab.

Product ID78206-162_488396cb-243a-45bf-b936-fcde5dcdb465
NDC78206-162
Product TypeHuman Prescription Drug
Proprietary NameRenflexis
Generic NameInfliximab
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-04-21
Marketing CategoryBLA /
Application NumberBLA761054
Labeler NameOrganon LLC
Substance NameINFLIXIMAB
Active Ingredient Strength100 mg/1
Pharm ClassesTumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 78206-162-01

1 VIAL in 1 CARTON (78206-162-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (78206-162-99)
Marketing Start Date2021-06-01
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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

Trademark Results [Renflexis]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RENFLEXIS
RENFLEXIS
87480588 5542207 Live/Registered
Merck Sharp & Dohme Corp.
2017-06-08
RENFLEXIS
RENFLEXIS
86307793 5311653 Live/Registered
Merck Sharp & Dohme Corp.
2014-06-12

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