Labeler · US market

Otsuka America Pharmaceutical, Inc.

Otsuka America Pharmaceutical, Inc. is a US drug labeler with US FDA registrations covering 17 drug concepts (17 currently active) across 80 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: OTSUKA PHARMACEUTICAL CO., LTD.

ACTIVE — US

openFDA · updated weekly

Labeler codes46602 · 59148

Active drugs17

Registrations63 active / 63

Packages80

Sole supplier of8 drugs

Portfolio17 drugs · US

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

Drug	Type	NDCs	Packages	Status
Aripiprazole tablet	rx	6	15	SUPPLYING
Aripiprazole tablet	other	12	12	SUPPLYING
Brexpiprazole tablet	rx	6	11	SUPPLYING
Brexpiprazole tablet	other	6	6	SUPPLYING
Tolvaptan kit	rx	5	5	SUPPLYING
Tolvaptan tablet	other	5	5	SUPPLYING
Aripiprazole kit	rx	4	5	SUPPLYING
Aripiprazole injection, powder, lyophilized, for suspension, extended release	other	4	4	SUPPLYING
Tolvaptan tablet	rx	4	4	SUPPLYING
Aripiprazole injection, suspension, extended release	rx	2	3	SUPPLYING
Dextromethorphan Hydrobromide And Quinidine Sulfate capsule, gelatin coated	rx	1	2	SUPPLYING
Aripiprazole injection, suspension, extended release	other	2	2	SUPPLYING
Brexpiprazole kit	rx	2	2	SUPPLYING
Sibeprenlimab injection	rx	1	1	SUPPLYING
Busulfan injection	rx	1	1	SUPPLYING
Brexpiprazole powder	other	1	1	SUPPLYING
Cedazuridine And Decitabine tablet	other	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes46602, 59148
Filing names2
Drugs (active)17
Drugs (all time)17
US registrations63
Packages80

Recent events

Shortages, recalls, and registration changes across all filing names.

Apr 9, 2024
RECALLRecall (Class III): Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC …
Apr 9, 2024
RECALLRecall (Class III): Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs …
Apr 9, 2024
RECALLRecall (Class III): Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC …
Apr 9, 2024
RECALLRecall (Class III): Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 5…
Nov 2, 2012
RECALLRecall (Class II): ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristo…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.