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NDC 65757-0653-41 LYBALVI 15; 10 mg/1; mg/1 Details
LYBALVI 15; 10 mg/1; mg/1
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.
MedlinePlus Drug Summary
The combination of olanzapine and samidorphan is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults. It is also used alone or with other medications to treat episodes of mania (frenzied, abnormally excited or irritated mood) in adults with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). The combination of olanzapine and samidorphan is also used to prevent episodes of mania in adults with bipolar disorder. Olanzapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain. Samidorphan is an opioid antagonist. It works to reduce possible side effects from olanzapine, including weight gain.
Related Packages: 65757-0653-41Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Olanzapine and Samidorphan
Product Information
| NDC | 65757-0653 |
|---|---|
| Product ID | 65757-653_f4ad4266-1f28-451a-bfb0-a31e7d746f6b |
| Associated GPIs | 62994802500330 |
| GCN Sequence Number | 082337 |
| GCN Sequence Number Description | olanzapine/samidorphan malate TABLET 15 MG-10MG ORAL |
| HIC3 | H7T |
| HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
| GCN | 49727 |
| HICL Sequence Number | 047406 |
| HICL Sequence Number Description | OLANZAPINE/SAMIDORPHAN MALATE |
| Brand/Generic | Brand |
| Proprietary Name | LYBALVI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | olanzapine and samidorphan L-malate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 15; 10 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | OLANZAPINE; SAMIDORPHAN L-MALATE |
| Labeler Name | Alkermes, Inc. |
| Pharmaceutical Class | Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA213378 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65757-0653-41 (65757065341)
| NDC Package Code | 65757-653-41 |
|---|---|
| Billing NDC | 65757065341 |
| Package | 1 BOTTLE in 1 CARTON (65757-653-41) / 7 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2021-09-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |