Home NDC 82454-0456 Ella
Product NDC 82454-0456
11-digit product format 824540456
Labeler code 82454
Product ID 82454-0456_d44e7ad5-eb62-1007-e053-2a95a90ae9f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ulipristal acetate
Dosage form TABLET
Route ORAL
Labeler CENEXI HSC
Application NDA022474
Marketing category NDA
Marketing start 2020-05-11
Marketing end 0000-00-00
Substance ULIPRISTAL ACETATE
Active strength 30 mg/1
Pharmacologic classes Progesterone Agonist/Antagonist [EPC],Selective Progesterone Receptor Modulators [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022474-001 ELLA ULIPRISTAL ACETATE 30MG TABLET / ORAL AB RLD, RS 2010-08-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022474-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022474-001 9844510 2028-12-08 Drug product 2019-04-18 N022474-001 8735380 2029-02-20 Drug product 2014-06-13 N022474-001 10159681 2030-04-13 U-2510 2019-04-18 N022474-001 10772897 2030-04-13 U-2958 2020-10-14 N022474-001 9283233 2030-04-13 U-1821 2016-03-16 N022474-001 8512745 2030-06-02 Drug product 2013-09-12 N022474-001 8426392 2030-06-12 U-1389 2013-05-07 N022474-001 8962603 2030-06-12 U-1657 2015-02-25
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 · 42 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 2026-08-18 06:07:40 2026-07 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022474-001 ELLA 30MG TABLET / ORAL AB RLD, RS 2010-08-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 9 · 331 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022474-001 9844510 2028-12-08 Drug product 2019-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022474-001 8735380 2029-02-20 Drug product 2014-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022474-001 10159681 2030-04-13 U-2510 2019-04-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022474-001 10772897 2030-04-13 U-2958 2020-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022474-001 9283233 2030-04-13 U-1821 2016-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022474-001 8512745 2030-06-02 Drug product 2013-09-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022474-001 8426392 2030-06-12 U-1389 2013-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022474-001 8962603 2030-06-12 U-1657 2015-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022474-001 9844510 2028-12-08 Drug product 2019-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022474-001 8735380 2029-02-20 Drug product 2014-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022474-001 10159681 2030-04-13 U-2510 2019-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022474-001 10772897 2030-04-13 U-2958 2020-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022474-001 9283233 2030-04-13 U-1821 2016-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022474-001 8512745 2030-06-02 Drug product 2013-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022474-001 8426392 2030-06-12 U-1389 2013-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022474-001 8962603 2030-06-12 U-1657 2015-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022474-001 9844510 2028-12-08 Drug product 2019-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022474-001 8735380 2029-02-20 Drug product 2014-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022474-001 10159681 2030-04-13 U-2510 2019-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022474-001 10772897 2030-04-13 U-2958 2020-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022474-001 9283233 2030-04-13 U-1821 2016-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022474-001 8512745 2030-06-02 Drug product 2013-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022474-001 8426392 2030-06-12 U-1389 2013-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022474-001 8962603 2030-06-12 U-1657 2015-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022474-001 9844510 2028-12-08 Drug product 2019-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022474-001 8735380 2029-02-20 Drug product 2014-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022474-001 10159681 2030-04-13 U-2510 2019-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022474-001 10772897 2030-04-13 U-2958 2020-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022474-001 9283233 2030-04-13 U-1821 2016-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022474-001 8512745 2030-06-02 Drug product 2013-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022474-001 8426392 2030-06-12 U-1389 2013-05-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022474-001 8962603 2030-06-12 U-1657 2015-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022474-001 9844510 2028-12-08 Drug product 2019-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022474-001 8735380 2029-02-20 Drug product 2014-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022474-001 10159681 2030-04-13 U-2510 2019-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022474-001 10772897 2030-04-13 U-2958 2020-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022474-001 9283233 2030-04-13 U-1821 2016-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022474-001 8512745 2030-06-02 Drug product 2013-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022474-001 8426392 2030-06-12 U-1389 2013-05-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022474-001 8962603 2030-06-12 U-1657 2015-02-25 fd3edfee7708…
Observed Orange Book exclusivity history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82454-0456-1 82454045601 1 BLISTER PACK in 1 CARTON (82454-0456-1) > 1 TABLET in 1 BLISTER PACK 1 blister pack 2020-05-11 0000-00-00 No No Current