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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202107-001KORLYMMIFEPRISTONE300MGTABLET / ORALABRLD, RS2012-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N202107-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202107-00189213482028-08-27U-16432015-01-27
N202107-001108428012032-11-15U-16432020-11-24
N202107-001105002162033-03-05U-16432019-12-10
N202107-001101662422036-04-20U-16432019-01-02
N202107-001101662432036-04-20U-16432019-01-02
N202107-001106609042036-04-20U-16432020-05-29
N202107-00199435262036-04-20U-16432018-04-17
N202107-001100069242036-08-12U-16432018-07-10
N202107-001104956502036-08-12U-16432019-12-03
N202107-00198294952036-08-15U-16432017-11-28
N202107-001101517632037-01-18U-16432018-12-12
N202107-001101952142037-06-19U-16432019-02-05
N202107-001108428002037-06-19U-16432020-11-24
N202107-001119694352037-06-19U-16432024-05-29
N202107-001120972102037-06-19U-16432024-09-25
N202107-001102319832038-08-22U-16432019-04-03
N202107-001103148502038-08-22U-16432019-06-14
N202107-001107800972038-08-22U-16432020-09-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202107-001KORLYM300MGTABLET / ORALRLD, RS2012-02-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202107-001KORLYM300MGTABLET / ORALRLD, RS2012-02-173f01610625f2…
2019-09-15 20:21 UTC2019-09N202107-001KORLYM300MGTABLET / ORALRLD, RS2012-02-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N202107-001KORLYM300MGTABLET / ORALRLD, RS2012-02-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N202107-001KORLYM300MGTABLET / ORALABRLD, RS2012-02-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N202107-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N202107-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202107-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202107-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202107-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202107-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202107-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202107-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202107-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202107-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202107-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202107-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202107-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202107-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202107-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202107-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N202107-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202107-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202107-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N202107-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202107-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202107-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202107-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202107-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202107-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202107-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202107-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202107-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202107-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N202107-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N202107-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202107-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N202107-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N202107-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N202107-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N202107-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 17 · 656 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N202107-00189213482028-08-27U-16432015-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001108428012032-11-15U-16432020-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001105002162033-03-05U-16432019-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001101662422036-04-20U-16432019-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001101662432036-04-20U-16432019-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001106609042036-04-20U-16432020-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-00199435262036-04-20U-16432018-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001100069242036-08-12U-16432018-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001104956502036-08-12U-16432019-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-00198294952036-08-15U-16432017-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001101517632037-01-18U-16432018-12-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001101952142037-06-19U-16432019-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001108428002037-06-19U-16432020-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001119694352037-06-19U-16432024-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001120972102037-06-19U-16432024-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001102319832038-08-22U-16432019-04-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001103148502038-08-22U-16432019-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202107-001107800972038-08-22U-16432020-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-00189213482028-08-27U-16432015-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001108428012032-11-15U-16432020-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001105002162033-03-05U-16432019-12-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001101662422036-04-20U-16432019-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001101662432036-04-20U-16432019-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001106609042036-04-20U-16432020-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-00199435262036-04-20U-16432018-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001100069242036-08-12U-16432018-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001104956502036-08-12U-16432019-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-00198294952036-08-15U-16432017-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001101517632037-01-18U-16432018-12-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001101952142037-06-19U-16432019-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001108428002037-06-19U-16432020-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001119694352037-06-19U-16432024-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001120972102037-06-19U-16432024-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001102319832038-08-22U-16432019-04-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001103148502038-08-22U-16432019-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202107-001107800972038-08-22U-16432020-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N202107-00189213482028-08-27U-16432015-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202107-001108428012032-11-15U-16432020-11-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202107-001105002162033-03-05U-16432019-12-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202107-001101662422036-04-20U-16432019-01-026a471c1ec25d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N202107-001ODE-222019-02-1774a2ff9319b5…
2019-12-14 00:12 UTC2019-12N202107-001ODE-222019-02-173f01610625f2…
2019-09-15 20:21 UTC2019-09N202107-001ODE-222019-02-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N202107-001ODE-222019-02-17ea99ee380514…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
320T6RNW1FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1245262Internal RxNorm lookup
1245268Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
542f3fae-8bc8-4f00-9228-e4b66c9ad6a9Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76346-073-01EA - Each76346-073862ad7a1-c2be-4ee2-94d9-ffdf49cd7ec112012-07-24
76346-073-02EA - Each76346-07350d04112-c77c-4d5d-8280-b84775eb9efb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIFEPRISTONEACTIVE INGREDIENT320T6RNW1FKORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
MIFEPRISTONEACTIVE MOIETY320T6RNW1FKORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933KORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GKORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8KORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PKORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HKORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2KORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5
TRIACETININACTIVE INGREDIENTXHX3C3X673KORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INC]5

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MifepristoneMIFEPRISTONECorcept Therapeutics Incorporated63c068cd-9370-460f-829b-70e8c7ebe91e2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 202107
application number: NDA202107
KorlymMIFEPRISTONECorcept Therapeutics Incorporated542f3fae-8bc8-4f00-9228-e4b66c9ad6a92025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 202107
application number: NDA202107
ndc (product): 76346-073

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