Labeler · US market

Alkermes, Inc.

Alkermes, Inc. is a US drug labeler with US FDA registrations covering 7 drug concepts (7 currently active) across 34 packages. It is currently the only active US supplier of 6 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes65757

Active drugs7

Registrations16 active / 16

Packages34

Sole supplier of6 drugs

Portfolio7 drugs · US

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

Drug	Type	NDCs	Packages	Status
Aripiprazole Lauroxil injection, suspension, extended release	other	4	12	SUPPLYING
Olanzapine And Samidorphan L-Malate tablet, film coated	rx	2	6	SUPPLYING
Olanzapine And Samidorphan L-Malate tablet, film coated	other	2	6	SUPPLYING
Risperidone injection, suspension	other	4	4	SUPPLYING
Aripiprazole Lauroxil injection, suspension, extended release	rx	1	3	SUPPLYING
Naltrexone kit	rx	2	2	SUPPLYING
Naltrexone injection, suspension	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.

Aripiprazole Lauroxilrx
Olanzapine And Samidorphan L-Malaterx
Aripiprazole Lauroxilother
Naltrexoneother
Olanzapine And Samidorphan L-Malateother
Risperidoneother

At a glance

TypeLabeler
Labeler codes65757
Filing names1
Drugs (active)7
Drugs (all time)7
US registrations16
Packages34

Recent events

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

Sep 26, 2019
RECALLRecall (Class II): Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 …
Aug 8, 2019
RECALLRecall (Class II): Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 …
Mar 4, 2014
RECALLRecall (Class II): VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured a…
Nov 6, 2012
RECALLRecall (Class II): VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit…

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; figures cover the entity across all its filing names.