1. Labeler Index
  2. Merck Sharp & Dohme Llc
  3. NDC Product Code: 0085-1366 Temodar

NDC 0085-1366 Temodar

Temozolomide Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0085-1366?
    5. Temodar 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

NDC Product Code:
0085-1366
Proprietary Name:
Temodar
Non-Proprietary Name: [1]
Temozolomide
Substance Name: [2]
Temozolomide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Merck Sharp & Dohme Llc
    Labeler Code:
    0085
    Product Label ID:
    046a9011-3911-4d3f-a15f-fbb56d5aad56
    FDA Application Number: [6]
    NDA021029
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    08-11-1999
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329)
    WHITE (C48325)
    YELLOW (C48330)
    PINK (C48328)
    Shape:
    CAPSULE (C48336)
    Size(s):
    16 MM
    17 MM
    19 MM
    Imprint(s):
    TEMODAR;5;MG
    TEMODAR;20;MG
    TEMODAR;100;MG
    Score:
    1

    Product Packages

    NDC Code 0085-1366-03

    Package Description: 5 PACKET in 1 CARTON / 1 CAPSULE in 1 PACKET (0085-1366-05)

    Price per Unit: $216.47138 per EA

    NDC Code 0085-1366-04

    Package Description: 14 PACKET in 1 CARTON / 1 CAPSULE in 1 PACKET (0085-1366-05)

    Price per Unit: $216.47138 per EA

    Product Details

    What is NDC 0085-1366?

    The NDC code 0085-1366 is assigned by the FDA to the product Temodar which is a human prescription drug product labeled by Merck Sharp & Dohme Llc. The generic name of Temodar is temozolomide. The product's dosage form is capsule and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0085-1366-03 5 packet in 1 carton / 1 capsule in 1 packet (0085-1366-05), 0085-1366-04 14 packet in 1 carton / 1 capsule in 1 packet (0085-1366-05). 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 Temodar?

    This medication is used to treat certain types of brain cancer. Temozolomide belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

    What are Temodar 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.
    • TEMOZOLOMIDE 100 mg/1 - A dacarbazine derivative that is used as an alkylating antineoplastic agent for the treatment of MALIGNANT GLIOMA and MALIGNANT MELANOMA.

    Which are Temodar UNII Codes?

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

    Which are Temodar 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 Temodar?

    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 Temodar?

    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

    Temozolomide


    Temozolomide is used to treat certain types of brain tumors. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.
    [Learn More]


    Cancer Chemotherapy


    What is cancer chemotherapy?

    Cancer chemotherapy is a type of cancer treatment. It uses medicines to destroy cancer cells.

    Normally, the cells in your body grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy works by killing the cancer cells, stopping them from spreading, or slowing their growth.

    Chemotherapy is used to:

    • Treat cancer by curing the cancer, lessening the chance it will return, or stopping or slowing its growth.
    • Ease cancer symptoms by shrinking tumors that are causing pain and other problems.

    What are the side effects of chemotherapy?

    Chemotherapy does not just destroy cancer cells. It can also harm some healthy cells, which causes side effects.

    You may have a lot of side effects, some side effects, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts.

    Some common side effects are:

    There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.

    What can I expect when getting chemotherapy?

    You may get chemotherapy in a hospital or at home, a doctor's office, or a medical clinic. You might be given the medicines by mouth, in a shot, as a cream, through a catheter, or intravenously (by IV).

    Your treatment plan will depend on the type of cancer you have, which chemotherapy medicines are used, the treatment goals, and how your body responds to the medicines.

    Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells.

    NIH: National Cancer Institute


    [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".