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 ID: 76346-073_28cc1a6b-0671-4e82-8bcf-6008e7b2404e
• NDC: 76346-073
• Product Type: Human Prescription Drug
• Proprietary Name: Korlym
• Generic Name: Mifepristone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2012-02-17
• Marketing Category: NDA / NDA
• Application Number: NDA202107
• Labeler Name: Corcept Therapeutics
• Substance Name: MIFEPRISTONE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Progestational Hormone Receptor Antagonists [MoA],Progestin Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 76346-073-01

28 TABLET in 1 BOTTLE (76346-073-01)

• Marketing Start Date: 2014-10-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76346-073-02 [76346007302]

Korlym TABLET

• Marketing Category: NDA
• Application Number: NDA202107
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-01-10

NDC 76346-073-01 [76346007301]

Korlym TABLET

• Marketing Category: NDA
• Application Number: NDA202107
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-03

Drug Details

Active Ingredients

Ingredient	Strength
MIFEPRISTONE	300 mg/1

OpenFDA Data

• SPL SET ID: 542f3fae-8bc8-4f00-9228-e4b66c9ad6a9
• Manufacturer:
  • Corcept Therapeutics
• UNII:
  • 320T6RNW1F
• 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"

NDC	Brand Name	Generic Name
76346-073	Korlym	Mifepristone
43393-001	Mifepristone	MIFEPRISTONE
83114-001	MIFEPRISTONE	mifepristone