Labeler · US market

Astellas Pharma US, Inc.

Astellas Pharma US, Inc. is a US drug labeler with US FDA registrations covering 25 drug concepts (22 currently active) across 47 packages. It is currently the only active US supplier of 13 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Astellas Pharma Inc.

ACTIVE — US

openFDA · updated weekly

Labeler codes0469 · 12838 · 51248 · 82829

Active drugs22

Registrations36 active / 40

Packages47

Sole supplier of13 drugs

Portfolio25 drugs · US

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

Drug	Type	NDCs	Packages	Status
Mirabegron tablet, film coated, extended release	rx	2	6	SUPPLYING
Fezolinetant tablet, film coated	rx	3	4	SUPPLYING
Tacrolimus Extended-Release Capsules capsule, coated, extended release	rx	3	3	SUPPLYING
Enzalutamide tablet	rx	3	3	SUPPLYING
Tacrolimus capsule, gelatin coated	rx	3	3	SUPPLYING
Tacrolimus granule, for suspension	rx	2	2	SUPPLYING
Zolbetuximab injection, powder, for suspension	rx	2	2	SUPPLYING
Avacincaptad Pegol injection	rx	1	2	SUPPLYING
Tacrolimus granule, for suspension	other	2	2	SUPPLYING
Enzalutamide capsule	rx	2	2	SUPPLYING
Isavuconazonium Sulfate capsule	rx	2	2	SUPPLYING
Gilteritinib tablet	rx	1	2	SUPPLYING
Fezolinetant tablet, coated	other	1	1	SUPPLYING
Isavuconazonium Sulfate powder	other	1	1	SUPPLYING
Tamsulosin Hydrochloride powder	other	1	1	SUPPLYING
Gilteritinib Fumarate tablet	other	1	1	SUPPLYING
Regadenoson injection, solution	rx	1	1	SUPPLYING
Mirabegron powder	other	1	1	SUPPLYING
Mirabegron granule, for suspension, extended release	rx	1	1	SUPPLYING
Amphotericin B injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Isavuconazonium Sulfate injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Tacrolimus injection, solution	rx	1	1	SUPPLYING
Solifenacin Succinate tablet, film coated	rx	2	2	DISCONTINUED
Solifenacin Succinate suspension	rx	1	1	DISCONTINUED
Micafungin Sodium injection, powder, lyophilized, for solution	rx	1	1	DISCONTINUED

Sole US supplier

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

+3 more

At a glance

TypeLabeler
Labeler codes0469, 12838, 51248, 82829
Filing names2
Drugs (active)22
Drugs (all time)25
US registrations40
Packages47

Recent events

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

Dec 23, 2024
RECALLRecall (Class I): Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by:…
Dec 23, 2024
RECALLRecall (Class I): Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharm…
Jan 22, 2018
RECALLRecall (Class II): Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbr…
Sep 15, 2014
RECALLRecall (Class II): Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Sey…
Jun 19, 2013
RECALLRecall (Class II): AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, M…

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.