NDC 65757-653

LYBALVI

Olanzapine And Samidorphan L-malate

LYBALVI is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alkermes, Inc.. The primary component is Olanzapine; Samidorphan L-malate.

• Product ID: 65757-653_0e150f4e-3766-4ab0-8bb5-5f1224eada9c
• NDC: 65757-653
• Product Type: Human Prescription Drug
• Proprietary Name: LYBALVI
• Generic Name: Olanzapine And Samidorphan L-malate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2021-09-20
• Marketing Category: NDA /
• Application Number: NDA213378
• Labeler Name: Alkermes, Inc.
• Substance Name: OLANZAPINE; SAMIDORPHAN L-MALATE
• Active Ingredient Strength: 15 mg/1; mg/1
• Pharm Classes: Atypical Antipsychotic [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 65757-653-40

1 BOTTLE in 1 CARTON (65757-653-40) > 7 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2021-09-20
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "LYBALVI" or generic name "Olanzapine And Samidorphan L-malate"

NDC	Brand Name	Generic Name
65757-651	LYBALVI	olanzapine and samidorphan L-malate
65757-652	LYBALVI	olanzapine and samidorphan L-malate
65757-653	LYBALVI	olanzapine and samidorphan L-malate
65757-654	LYBALVI	olanzapine and samidorphan L-malate