Lybalvi Tablet, Film Coated
NDC 65757-652

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 65757-652?
  5. Lybalvi Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Lybalvi (olanzapine and samidorphan l-malate) is a NDA-approved product labeled by Alkermes, Inc.. This medication is typically used as a atypical antipsychotic [epc]. It is supplied as a yellow tablet, film coated for oral administration. This product entry covers the primary NDC 65757-652 and 5 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
65757-652
Proprietary Name:
Lybalvi
Non-Proprietary Name: [1]
Olanzapine And Samidorphan L-malate
Substance Name: [2]
Olanzapine; Samidorphan L-malate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Alkermes, Inc.
Labeler Code:
65757
Product Label ID:
32ffddd1-4e2b-45d9-9b36-bb730167ec80
FDA Application Number: [6]
NDA213378
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-20-2021
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330 - YELLOW)
ORANGE (C48331 - ORANGE)
Shape:
CAPSULE (C48336)
Size(s):
9 MM
10 MM
Imprint(s):
OS;5
OS;10
Score:
1

Code Structure Chart

Product Details

What is NDC 65757-652?

The NDC code 65757-652 is assigned by the FDA to the product Lybalvi. It is commonly known by its generic name, olanzapine and samidorphan l-malate. This pharmaceutical product is labeled by Alkermes, Inc. and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in 5 different package configurations. The associated package NDC(s) include: 65757-652-02, 65757-652-40, 65757-652-41, 65757-652-42, 65757-652-44. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

LYBALVI is indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • OLANZAPINE 10 mg/1 - A benzodiazepine derivative that binds SEROTONIN RECEPTORS; MUSCARINIC RECEPTORS; HISTAMINE H1 RECEPTORS; ADRENERGIC ALPHA-1 RECEPTORS; and DOPAMINE RECEPTORS. It is an antipsychotic agent used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER; and MAJOR DEPRESSIVE DISORDER; it may also reduce nausea and vomiting in patients undergoing chemotherapy.
  • SAMIDORPHAN L-MALATE 10 mg/1
  • OLANZAPINE 10 mg/1 - A benzodiazepine derivative that binds SEROTONIN RECEPTORS; MUSCARINIC RECEPTORS; HISTAMINE H1 RECEPTORS; ADRENERGIC ALPHA-1 RECEPTORS; and DOPAMINE RECEPTORS. It is an antipsychotic agent used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER; and MAJOR DEPRESSIVE DISORDER; it may also reduce nausea and vomiting in patients undergoing chemotherapy.
  • SAMIDORPHAN L-MALATE 10 mg/1

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 2570392 - OLANZapine 5 MG / samidorphan 10 MG Oral Tablet
  • RxCUI: 2570392 - olanzapine 5 MG / samidorphan 10 MG Oral Tablet
  • RxCUI: 2570392 - olanzapine 5 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG) Oral Tablet
  • RxCUI: 2570398 - LYBALVI 5 MG / 10 MG Oral Tablet
  • RxCUI: 2570398 - olanzapine 5 MG / samidorphan 10 MG Oral Tablet [Lybalvi]

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Olanzapine and Samidorphan


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.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".