Korlym

Product NDC
76346-073
11-digit product format
763460073
Labeler code
76346
Product ID
76346-073_f9fd7845-859c-49d4-a1f9-b96b591c4021
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mifepristone
Dosage form
TABLET
Route
ORAL
Labeler
Corcept Therapeutics Incorporated
Application
NDA202107
Marketing category
NDA
Marketing start
2012-02-17
Substance
MIFEPRISTONE
Active strength
300 mg/1
Pharmacologic classes
Progestational Hormone Receptor Antagonists [MoA], Progestin Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Korlym
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIFEPRISTONE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii320T6RNW1F
Rxcui1245262, 1245268

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9f80ed59-2511-7c3d-8726-727ad4e34951Product name220210223
d77d5635-fbfa-4e46-b227-bea7fc095975Product name120190710

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76346-073-01Korlym28 in 1 BOTTLETABLET2826
76346-073-02Korlym280 in 1 BOTTLETABLET28026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76346-073KORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INCORPORATED]25Current NDC, Legacy NDC, 2 package rows20250125_542f3fae-8bc8-4f00-9228-e4b66c9ad6a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245268Korlym 300 MG Oral TabletPSN542f3fae-8bc8-4f00-9228-e4b66c9ad6a926
1245262miFEPRIStone 300 MG Oral TabletPSN542f3fae-8bc8-4f00-9228-e4b66c9ad6a926
1245268mifepristone 300 MG Oral Tablet [Korlym]SBD542f3fae-8bc8-4f00-9228-e4b66c9ad6a926
1245262mifepristone 300 MG Oral TabletSCD542f3fae-8bc8-4f00-9228-e4b66c9ad6a926
1245268Korlym 300 MG Oral TabletSY542f3fae-8bc8-4f00-9228-e4b66c9ad6a926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76346-073-017634600730128 TABLET in 1 BOTTLE (76346-073-01) 28 tablet2012-02-170000-00-00NoNoCurrent
76346-073-0276346007302280 TABLET in 1 BOTTLE (76346-073-02) 280 tablet2012-02-170000-00-00NoNoCurrent