Home NDC 42806-708 Ethosuximide
Product NDC 42806-708
11-digit product format 428060708
Labeler code 42806
Product ID 42806-708_2b206d5a-4881-923b-e063-6294a90a13b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethosuximide
Dosage form CAPSULE
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA210654
Marketing category ANDA
Marketing start 2021-11-12
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A210654-001 ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210654-001 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.
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 2026-09-14 22:38:34 2026-08 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL BX 2020-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL BX 2020-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL BX 2020-03-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL BX 2020-03-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL BX 2020-03-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL BX 2020-03-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL BX 2020-03-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL BX 2020-03-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL BX 2020-03-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ethosuximide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHOSUXIMIDE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5SEH9X1D1D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197682 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 42806-708-01 Ethosuximide 100 in 1 BOTTLE CAPSULE 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-708 ETHOSUXIMIDE CAPSULE [EPIC PHARMA, LLC] 9 Current NDC, 1 package rows 20250109_85c50760-98cc-4888-b27f-146937acc893.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 Sample Exclude flag Status 42806-708-01 42806070801 100 CAPSULE in 1 BOTTLE (42806-708-01) 100 capsule 2021-11-12 No No Current