NDC 50072-010

TPOXX

Tecovirimat Monohydrate

TPOXX is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Siga Technologies, Inc.. The primary component is Tecovirimat.

Product ID50072-010_70b3a765-cf50-476b-904d-0d272bcc8a72
NDC50072-010
Product TypeHuman Prescription Drug
Proprietary NameTPOXX
Generic NameTecovirimat Monohydrate
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-05-31
Marketing CategoryNDA /
Application NumberNDA214518
Labeler NameSIGA Technologies, Inc.
Substance NameTECOVIRIMAT
Active Ingredient Strength10 mg/mL
Pharm ClassesBreast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50072-010-01

7 VIAL in 1 CARTON (50072-010-01) > 20 mL in 1 VIAL (50072-010-30)
Marketing Start Date2022-05-31
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "TPOXX" or generic name "Tecovirimat Monohydrate"

NDCBrand NameGeneric Name
50072-010TPOXXtecovirimat monohydrate
50072-200TPOXXtecovirimat monohydrate

Trademark Results [TPOXX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TPOXX
TPOXX
86409863 5046109 Live/Registered
SIGA Technologies, Inc.
2014-09-30

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