Home NDC 43393-001 Mifepristone
Product NDC 43393-001
11-digit product format 433930001
Labeler code 43393
Product ID 43393-001_38fb9b4e-422b-35d9-e063-6394a90a8300
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MIFEPRISTONE
Dosage form TABLET
Route ORAL
Labeler GenBioPro, Inc.
Application ANDA091178
Marketing category ANDA
Marketing start 2019-05-01
Substance MIFEPRISTONE
Active strength 200 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 A091178-001 MIFEPRISTONE MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091178-001 AB
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 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091178-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2019-04-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Mifepristone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIFEPRISTONE 200 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311704 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 43393-001-01 Mifepristone 1 in 1 BLISTER PACK TABLET 1 9 43393-001-06 Mifepristone 6 in 1 PACKAGE TABLET 6 9 43393-001-06 Mifepristone 1 in 1 CARTON TABLET 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43393-001 MIFEPRISTONE TABLET [GENBIOPRO, INC.] 8 Current NDC, Legacy NDC, 3 package rows 20230404_b63fad9b-7f12-4400-9019-b0586054e534.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 · 1 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 43393-001-01 43393000101 1 in 1 BLISTER PACK Historical 43393-001-06 43393000106 6 CARTON in 1 PACKAGE (43393-001-06) / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01) 6 carton 2019-05-01 0000-00-00 No No Current