NDC 76346-073

Korlym

Mifepristone

Korlym is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Corcept Therapeutics. The primary component is Mifepristone.

Product ID76346-073_28cc1a6b-0671-4e82-8bcf-6008e7b2404e
NDC76346-073
Product TypeHuman Prescription Drug
Proprietary NameKorlym
Generic NameMifepristone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-02-17
Marketing CategoryNDA / NDA
Application NumberNDA202107
Labeler NameCorcept Therapeutics
Substance NameMIFEPRISTONE
Active Ingredient Strength300 mg/1
Pharm ClassesProgestational Hormone Receptor Antagonists [MoA],Progestin Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76346-073-01

28 TABLET in 1 BOTTLE (76346-073-01)
Marketing Start Date2014-10-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76346-073-02 [76346007302]

Korlym TABLET
Marketing CategoryNDA
Application NumberNDA202107
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-10

NDC 76346-073-01 [76346007301]

Korlym TABLET
Marketing CategoryNDA
Application NumberNDA202107
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-03

Drug Details

Active Ingredients

IngredientStrength
MIFEPRISTONE300 mg/1

OpenFDA Data

SPL SET ID:542f3fae-8bc8-4f00-9228-e4b66c9ad6a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1245262
  • 1245268
  • UPC Code
  • 0376346073023
  • 0376346073016
  • Pharmacological Class

    • Progestational Hormone Receptor Antagonists [MoA]
    • Progestin Antagonist [EPC]

    NDC Crossover Matching brand name "Korlym" or generic name "Mifepristone"

    NDCBrand NameGeneric Name
    76346-073KorlymMifepristone
    43393-001MifepristoneMIFEPRISTONE
    83114-001MIFEPRISTONEmifepristone

    Trademark Results [Korlym]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KORLYM
    KORLYM
    90792899 not registered Live/Pending
    CORCEPT THERAPEUTICS INCORPORATED
    2021-06-24
    KORLYM
    KORLYM
    88976826 not registered Live/Pending
    CORCEPT THERAPEUTICS INCORPORATED
    2019-01-30
    KORLYM
    KORLYM
    88282423 not registered Live/Pending
    CORCEPT THERAPEUTICS INCORPORATED
    2019-01-30
    KORLYM
    KORLYM
    86699675 not registered Dead/Abandoned
    CORCEPT THERAPEUTICS, INC.
    2015-07-21
    KORLYM
    KORLYM
    85218444 4313527 Live/Registered
    Corcept Therapeutics, Inc.
    2011-01-14

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