Alkermes, Inc.

Alkermes, Inc. lists 16 drug products in the FDA National Drug Code directory.

Products

NDC	Product	Strength	Type
65757-401	Aristada Injection, Suspension, Extended Release	Aripiprazole Lauroxil 441 mg/1.6mL	Rx
65757-402	Aristada Injection, Suspension, Extended Release	Aripiprazole Lauroxil 662 mg/2.4mL	Rx
65757-403	Aristada Injection, Suspension, Extended Release	Aripiprazole Lauroxil 882 mg/3.2mL	Rx
65757-404	Aristada Injection, Suspension, Extended Release	Aripiprazole Lauroxil 1064 mg/3.9mL	Rx
65757-500	Aristada Initio Injection, Suspension, Extended Release	Aripiprazole Lauroxil 675 mg/2.4mL	Rx
13551-001	Lumryz For Suspension, Extended Release	Sodium Oxybate 4.5 g/1	Rx
13551-002	Lumryz For Suspension, Extended Release	Sodium Oxybate 6 g/1	Rx
13551-003	Lumryz For Suspension, Extended Release	Sodium Oxybate 7.5 g/1	Rx
13551-004	Lumryz For Suspension, Extended Release	Sodium Oxybate 9 g/1	Rx
13551-005	Lumryz Kit		Rx
65757-651	Lybalvi Tablet, Film Coated	Olanzapine 5 mg/1; Samidorphan L-malate 10 mg/1	Rx
65757-652	Lybalvi Tablet, Film Coated	Olanzapine 10 mg/1; Samidorphan L-malate 10 mg/1	Rx
65757-653	Lybalvi Tablet, Film Coated	Olanzapine 15 mg/1; Samidorphan L-malate 10 mg/1	Rx
65757-654	Lybalvi Tablet, Film Coated	Olanzapine 20 mg/1; Samidorphan L-malate 10 mg/1	Rx
65757-300	Vivitrol Kit		Rx
65757-301	Vivitrol Kit		Rx

D-0119-2020 Oct 9, 2019 · Class II
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not…
D-1556-2014 Sep 3, 2014 · Class II
Customer complaints for failure to deliver the dose.
D-819-2013 Jul 31, 2013 · Class II
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.