Home NDC 63629-8005-1 Ethosuximide
Product NDC 63629-8005
Requested package NDC 63629-8005-1
11-digit product format 636298005
Labeler code 63629
Product ID 63629-8005_e5905131-91d2-403b-948c-da995b7ebebc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethosuximide
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA040430
Marketing category ANDA
Marketing start 2016-10-21
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 63629-8005 63629-8005-1 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 63629-8005 63629-8005-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A040430-001 ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040430-001 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 · 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 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040430-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2002-10-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-8005-1 Ethosuximide 90 in 1 BOTTLE CAPSULE, LIQUID FILLED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8005 ETHOSUXIMIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] 3 Current NDC, Legacy NDC, 1 package rows 20240515_867b54c4-4ce4-4c00-a03b-f108f1000e29.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 Marketing start Marketing end Sample Exclude flag Status 63629-8005-1 63629800501 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8005-1) 2019-05-09 0000-00-00 No No Current