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NDC 43393-0001-06 Mifepristone 200 mg/1 Details
Mifepristone 200 mg/1
Mifepristone is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GenBioPro, Inc.. The primary component is MIFEPRISTONE.
MedlinePlus Drug Summary
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.
Related Packages: 43393-0001-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mifepristone (Korlym)
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.
Related Packages: 43393-0001-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Mifepristone (Mifeprex)
Product Information
NDC | 43393-0001 |
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Product ID | 43393-001_f827a5f5-c021-61dd-e053-6294a90a94d9 |
Associated GPIs | 30502060000320 |
GCN Sequence Number | 046706 |
GCN Sequence Number Description | mifepristone TABLET 200 MG ORAL |
HIC3 | G8D |
HIC3 Description | ABORTIFACIENT-PROGESTERONE RECEPTOR ANTAGONISTS |
GCN | 12207 |
HICL Sequence Number | 007325 |
HICL Sequence Number Description | MIFEPRISTONE |
Brand/Generic | Generic |
Proprietary Name | Mifepristone |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | MIFEPRISTONE |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 200 |
Active Ingredient Units | mg/1 |
Substance Name | MIFEPRISTONE |
Labeler Name | GenBioPro, Inc. |
Pharmaceutical Class | Progestational Hormone Receptor Antagonists [MoA], Progestin Antagonist [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA091178 |
Listing Certified Through | 2024-12-31 |
Package
NDC 43393-0001-06 (43393000106)
NDC Package Code | 43393-001-06 |
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Billing NDC | 43393000106 |
Package | 6 CARTON in 1 PACKAGE (43393-001-06) / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01) |
Marketing Start Date | 2019-05-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |