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  4. NDC Product Code: 43393-001 Mifepristone

NDC 43393-001 Mifepristone

Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 43393-001?
  5. Mifepristone 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:
43393-001
Proprietary Name:
Mifepristone
Non-Proprietary Name: [1]
Mifepristone
Substance Name: [2]
Mifepristone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Genbiopro, Inc.
    Labeler Code:
    43393
    Product Label ID:
    b63fad9b-7f12-4400-9019-b0586054e534
    FDA Application Number: [6]
    ANDA091178
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    05-01-2019
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330)
    Shape:
    ROUND (C48348)
    Size(s):
    11 MM
    Imprint(s):
    S
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 43393-001?

    The NDC code 43393-001 is assigned by the FDA to the product Mifepristone which is a human prescription drug product labeled by Genbiopro, Inc.. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 43393-001-06 6 carton in 1 package / 1 blister pack in 1 carton / 1 tablet in 1 blister pack (43393-001-01). 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 Mifepristone?

    Mifepristone (also known as RU 486) is used to cause an abortion during the early part of a pregnancy. It is used up to week 10 of pregnancy (up to 70 days after the first day of your last menstrual period). Mifepristone blocks a natural substance (progesterone) that is needed for your pregnancy to continue. It is usually used together with another medicine called misoprostol. Mifepristone must not be used if you have a rare abnormal pregnancy that is outside the womb (ectopic pregnancy). It will not cause an abortion in this case. It may cause an ectopic pregnancy to rupture, resulting in very serious bleeding.

    What are Mifepristone 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.
    • MIFEPRISTONE 200 mg/1 - A progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary CUSHING SYNDROME.

    Which are Mifepristone UNII Codes?

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

    Which are Mifepristone 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 Mifepristone?

    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 Mifepristone?

    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

    Mifepristone (Korlym)


    Mifepristone (Korlym) is used to treat hyperglycemia (high blood sugar) in people with a certain type of Cushing's syndrome in which the body makes too much cortisol (a hormone) and who have failed surgery or cannot have surgery to treat this condition. Mifepristone is in a class of medications called cortisol receptor blockers. It works by blocking the activity of cortisol. Mifepristone is also available as another product (Mifeprex) that is used alone or in combination with another medication to end an early pregnancy. This monograph only gives information about mifepristone (Korlym) used to control hyperglycemia in people with a certain type of Cushing's syndrome. If you are using mifepristone to terminate a pregnancy, read the monograph entitled mifepristone (Mifeprex), which has been written about this product.
    [Learn More]


    Mifepristone (Mifeprex)


    Mifepristone is used in combination with misoprostol (Cytotec) to end an early pregnancy. Early pregnancy means it has been 70 days or less since your last menstrual period began. Mifepristone is in a class of medications called antiprogestational steroids. It works by blocking the activity of progesterone, a substance your body makes to help continue pregnancy. Mifepristone is also available as another product (Korlym), which is used to control hyperglycemia (high blood sugar) in people with a certain type of Cushing's Syndrome in which the body makes too much of the hormone cortisol. This monograph only gives information about mifepristone (Mifeprex), which is used alone or in combination with another medication to end an early pregnancy. If you are using mifepristone to control hyperglycemia caused by Cushing's syndrome, read the monograph entitled mifepristone (Korlym) that has been written about this product.
    [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".