NDC 0078-0457 Trileptal

Oxcarbazepine Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0078-0457
Proprietary Name:
Trileptal
Non-Proprietary Name: [1]
Oxcarbazepine
Substance Name: [2]
Oxcarbazepine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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 Name: [5]
    Novartis Pharmaceuticals Corporation
    Labeler Code:
    0078
    FDA Application Number: [6]
    NDA021014
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    01-30-2000
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329 - PALE GREY-GREEN)
    YELLOW (C48330)
    PINK (C48328 - LIGHT PINK)
    Shape:
    OVAL (C48345)
    Size(s):
    11 MM
    15 MM
    19 MM
    Imprint(s):
    T;D;C;G
    TE;TE;CG;CG
    TF;TF;CG;CG
    Score:
    2

    Product Packages

    NDC Code 0078-0457-05

    Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $18.31204 per EA

    NDC Code 0078-0457-35

    Package Description: 100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0457-61)

    Product Details

    What is NDC 0078-0457?

    The NDC code 0078-0457 is assigned by the FDA to the product Trileptal which is a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Trileptal is oxcarbazepine. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0078-0457-05 100 tablet, film coated in 1 bottle , 0078-0457-35 100 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack (0078-0457-61). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Trileptal?

    Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy). TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in pediatric patients aged 4 years and above with epilepsy, and as adjunctive therapy in pediatric patients aged 2 years and above with partial seizures. 

    What are Trileptal Active Ingredients?

    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.
    • OXCARBAZEPINE 600 mg/1 - A carbamazepine derivative that acts as a voltage-gated sodium channel blocker. It is used for the treatment of PARTIAL SEIZURES with or without secondary generalization. It is also an inducer of CYTOCHROME P-450 CYP3A4.

    Which are Trileptal UNII Codes?

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

    Which are Trileptal Inactive Ingredients 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 Trileptal?

    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:

    Which are the Pharmacologic Classes for Trileptal?

    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.

    * Please review the disclaimer below.

    Patient Education

    Oxcarbazepine


    Oxcarbazepine (Trileptal) is used alone or in combination with other medications to control certain types of seizures in adults and children. Oxcarbazepine extended-release tablets (Oxtellar XR) are used in combination with other medications to control certain types of seizures in adults and children 6 years of age and older. Oxcarbazepine is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".