Home NDC 76346-073 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202107-001 KORLYM MIFEPRISTONE 300MG TABLET / ORAL AB RLD, RS 2012-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202107-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202107-001 KORLYM 300MG TABLET / ORAL RLD, RS 2012-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202107-001 KORLYM 300MG TABLET / ORAL RLD, RS 2012-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202107-001 KORLYM 300MG TABLET / ORAL RLD, RS 2012-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202107-001 KORLYM 300MG TABLET / ORAL RLD, RS 2012-02-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202107-001 KORLYM 300MG TABLET / ORAL AB RLD, RS 2012-02-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 17 · 656 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202107-001 8921348 2028-08-27 U-1643 2015-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10842801 2032-11-15 U-1643 2020-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10500216 2033-03-05 U-1643 2019-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10166242 2036-04-20 U-1643 2019-01-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10166243 2036-04-20 U-1643 2019-01-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10660904 2036-04-20 U-1643 2020-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 9943526 2036-04-20 U-1643 2018-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10006924 2036-08-12 U-1643 2018-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10495650 2036-08-12 U-1643 2019-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 9829495 2036-08-15 U-1643 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10151763 2037-01-18 U-1643 2018-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10195214 2037-06-19 U-1643 2019-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10842800 2037-06-19 U-1643 2020-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 11969435 2037-06-19 U-1643 2024-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 12097210 2037-06-19 U-1643 2024-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10231983 2038-08-22 U-1643 2019-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10314850 2038-08-22 U-1643 2019-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202107-001 10780097 2038-08-22 U-1643 2020-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 8921348 2028-08-27 U-1643 2015-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10842801 2032-11-15 U-1643 2020-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10500216 2033-03-05 U-1643 2019-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10166242 2036-04-20 U-1643 2019-01-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10166243 2036-04-20 U-1643 2019-01-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10660904 2036-04-20 U-1643 2020-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 9943526 2036-04-20 U-1643 2018-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10006924 2036-08-12 U-1643 2018-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10495650 2036-08-12 U-1643 2019-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 9829495 2036-08-15 U-1643 2017-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10151763 2037-01-18 U-1643 2018-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10195214 2037-06-19 U-1643 2019-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10842800 2037-06-19 U-1643 2020-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 11969435 2037-06-19 U-1643 2024-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 12097210 2037-06-19 U-1643 2024-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10231983 2038-08-22 U-1643 2019-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10314850 2038-08-22 U-1643 2019-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202107-001 10780097 2038-08-22 U-1643 2020-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202107-001 8921348 2028-08-27 U-1643 2015-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202107-001 10842801 2032-11-15 U-1643 2020-11-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202107-001 10500216 2033-03-05 U-1643 2019-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202107-001 10166242 2036-04-20 U-1643 2019-01-02 6a471c1ec25d…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N202107-001 ODE-22 2019-02-17 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N202107-001 ODE-22 2019-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202107-001 ODE-22 2019-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202107-001 ODE-22 2019-02-17 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Korlym
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIFEPRISTONE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 320T6RNW1F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1245262 Internal RxNorm lookup 1245268 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76346-073-01 Korlym 28 in 1 BOTTLE TABLET 28 26 76346-073-02 Korlym 280 in 1 BOTTLE TABLET 280 26
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76346-073 KORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INCORPORATED] 25 Current NDC, Legacy NDC, 2 package rows 20250125_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76346-073-01 76346007301 28 TABLET in 1 BOTTLE (76346-073-01) 28 tablet 2012-02-17 0000-00-00 No No Current 76346-073-02 76346007302 280 TABLET in 1 BOTTLE (76346-073-02) 280 tablet 2012-02-17 0000-00-00 No No Current