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Labeler · US market

Shionogi Pharma Co., Ltd.

Shionogi Pharma Co., Ltd. is a US drug labeler with US FDA registrations covering 13 drug concepts (13 currently active) across 18 packages. It is currently the only active US supplier of 8 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: SHIONOGI INC.

ACTIVE — US
openFDA · updated weekly
Labeler codes53044 · 59630 · 70510
Active drugs13
Registrations17 active / 17
Packages18
Sole supplier of8 drugs

Portfolio13 drugs · US

Every drug concept this labeler has US registrations for, by package count.

DrugTypeNDCsPackagesStatus
Baloxavir Marboxil
tablet, coated
other33SUPPLYING
Edaravone
kit
rx22SUPPLYING
Lusutrombopag
tablet, film coated
rx12SUPPLYING
Methylphenidate Hydrochloride
solution
rx22SUPPLYING
Baloxavir Marboxil
powder
other11SUPPLYING
Cefiderocol Sulfate Tosylate
powder
other11SUPPLYING
Naldemedine Tosylate
powder
other11SUPPLYING
Baloxavir Marboxil
granule, for suspension
other11SUPPLYING
Edaravone
powder
other11SUPPLYING
Cefiderocol Sulfate Tosylate
injection, powder, for solution
rx11SUPPLYING
Ensitrelvir
tablet
rx11SUPPLYING
Dolutegravir Sodium
powder
other11SUPPLYING
Lusutrombopag
powder
other11SUPPLYING