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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022474-001ELLAULIPRISTAL ACETATE30MGTABLET / ORALABRLD, RS2010-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022474-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022474-00198445102028-12-08Drug product2019-04-18
N022474-00187353802029-02-20Drug product2014-06-13
N022474-001101596812030-04-13U-25102019-04-18
N022474-001107728972030-04-13U-29582020-10-14
N022474-00192832332030-04-13U-18212016-03-16
N022474-00185127452030-06-02Drug product2013-09-12
N022474-00184263922030-06-12U-13892013-05-07
N022474-00189626032030-06-12U-16572015-02-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-133f01610625f2…
2019-09-15 20:21 UTC2019-09N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022474-001ELLA30MGTABLET / ORALABRLD, RS2010-08-13e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N022474-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022474-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022474-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022474-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022474-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022474-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022474-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022474-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022474-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022474-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022474-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022474-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022474-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022474-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022474-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022474-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022474-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022474-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022474-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022474-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022474-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022474-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022474-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022474-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022474-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022474-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N022474-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022474-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022474-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022474-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022474-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022474-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022474-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022474-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022474-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022474-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022474-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022474-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022474-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022474-001AB1e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 9 · 331 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N022474-00198445102028-12-08Drug product2019-04-18caaa826d4ba7…
2026-08-18 06:07:402026-07N022474-00187353802029-02-20Drug product2014-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N022474-001101596812030-04-13U-25102019-04-18caaa826d4ba7…
2026-08-18 06:07:402026-07N022474-001107728972030-04-13U-29582020-10-14caaa826d4ba7…
2026-08-18 06:07:402026-07N022474-00192832332030-04-13U-18212016-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N022474-00185127452030-06-02Drug product2013-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07N022474-00184263922030-06-12U-13892013-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022474-00189626032030-06-12U-16572015-02-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022474-00198445102028-12-08Drug product2019-04-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022474-00187353802029-02-20Drug product2014-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022474-001101596812030-04-13U-25102019-04-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022474-001107728972030-04-13U-29582020-10-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022474-00192832332030-04-13U-18212016-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022474-00185127452030-06-02Drug product2013-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022474-00184263922030-06-12U-13892013-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022474-00189626032030-06-12U-16572015-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022474-00198445102028-12-08Drug product2019-04-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022474-00187353802029-02-20Drug product2014-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022474-001101596812030-04-13U-25102019-04-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022474-001107728972030-04-13U-29582020-10-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022474-00192832332030-04-13U-18212016-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022474-00185127452030-06-02Drug product2013-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022474-00184263922030-06-12U-13892013-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022474-00189626032030-06-12U-16572015-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022474-00198445102028-12-08Drug product2019-04-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022474-00187353802029-02-20Drug product2014-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022474-001101596812030-04-13U-25102019-04-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022474-001107728972030-04-13U-29582020-10-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022474-00192832332030-04-13U-18212016-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022474-00185127452030-06-02Drug product2013-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022474-00184263922030-06-12U-13892013-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022474-00189626032030-06-12U-16572015-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022474-00198445102028-12-08Drug product2019-04-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022474-00187353802029-02-20Drug product2014-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022474-001101596812030-04-13U-25102019-04-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022474-001107728972030-04-13U-29582020-10-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022474-00192832332030-04-13U-18212016-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022474-00185127452030-06-02Drug product2013-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022474-00184263922030-06-12U-13892013-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022474-00189626032030-06-12U-16572015-02-25fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022474-001M-2712024-06-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022474-001M-2712024-06-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022474-001M-2712024-06-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022474-001M-2712024-06-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022474-001M-2712024-06-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022474-001M-2712024-06-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022474-001M-2712024-06-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022474-001M-2712024-06-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022474-001M-2712024-06-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022474-001M-2712024-06-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022474-001M-2712024-06-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022474-001M-2712024-06-244b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022474-001M-2712024-06-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022474-001M-2712024-06-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022474-001M-2712024-06-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022474-001M-2712024-06-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022474-001M-2712024-06-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022474-001M-2712024-06-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022474-001M-2712024-06-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N022474-001M-2712024-06-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N022474-001M-2712024-06-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022474-001M-2712024-06-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022474-001M-2712024-06-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022474-001M-2712024-06-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022474-001M-2712024-06-24cb3db0bc1861…

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
EllaULIPRISTAL ACETATEPMI Branded Pharmaceuticals, Inc.2bf93d23-cddd-4613-9066-5b5fa090404b2026-07-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 022474
application number: NDA022474
EllaULIPRISTAL ACETATEA-S Medication Solutionse5f09468-7ac8-40ba-a85b-758a32f586c32023-02-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 022474
application number: NDA022474

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82454-0456-1824540456011 BLISTER PACK in 1 CARTON (82454-0456-1) > 1 TABLET in 1 BLISTER PACK1 blister pack2020-05-110000-00-00NoNoCurrent