ETHOSUXIMIDE

Product NDC
23155-532
11-digit product format
231550532
Labeler code
23155
Product ID
23155-532_b7244494-bae5-4434-9b8f-d5ed6d33619a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETHOSUXIMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA200892
Marketing category
ANDA
Marketing start
2015-09-09
Marketing end
0000-00-00
Substance
ETHOSUXIMIDE
Active strength
250 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct23155-532DDiscontinued by firm2026-08-17
excluded packagepackage23155-53223155-532-01DDiscontinued by firm2026-08-17
excluded packagepackage23155-53223155-532-05DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct23155-532IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage23155-53223155-532-01IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage23155-53223155-532-05IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
A200892-001ETHOSUXIMIDEETHOSUXIMIDE250MGCAPSULE / ORAL2012-09-25

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 06:07:402026-07A200892-001ETHOSUXIMIDE250MGCAPSULE / ORAL2012-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALBX2012-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALBX2012-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALBX2012-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALBX2012-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALBX2012-09-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-253f01610625f2…
2019-09-15 20:21 UTC2019-09A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALAB2012-09-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALBX2012-09-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALBX2012-09-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200892-001ETHOSUXIMIDE250MGCAPSULE / ORALBX2012-09-25e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200892-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200892-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200892-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200892-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200892-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200892-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200892-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200892-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200892-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200892-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200892-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200892-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200892-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200892-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200892-001BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200892-001BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200892-001BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200892-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200892-001BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200892-001BX1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200892-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A200892-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200892-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200892-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200892-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A200892-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200892-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200892-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200892-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200892-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200892-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200892-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200892-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200892-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200892-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200892-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200892-001BX13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200892-001BX1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200892-001BX1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200892-001BX1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-532-01EA - Each23155-532dab1b6bc-4752-4d47-ad40-3613d037b08112016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHOSUXIMIDEACTIVE INGREDIENT5SEH9X1D1DETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
ETHOSUXIMIDEACTIVE MOIETY5SEH9X1D1DETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
GELATININACTIVE INGREDIENT2G86QN327LETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-532ETHOSUXIMIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Legacy NDC20211230_0d0965f7-d780-4d1c-8ecf-77387483cc02.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ETHOSUXIMIDEETHOSUXIMIDEChartwell RX, LLC43fdfd16-c723-452a-9c1d-accf6f7c622e2024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200892
application number: ANDA200892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-532-0123155053201100 CAPSULE in 1 BOTTLE (23155-532-01) 100 capsule2015-09-090000-00-00NoNoCurrent
23155-532-0523155053205500 CAPSULE in 1 BOTTLE (23155-532-05) 500 capsule2015-09-090000-00-00NoNoCurrent