Home NDC 62135-064 Ethosuximide
Product NDC 62135-064
11-digit product format 621350064
Labeler code 62135
Product ID 62135-064_52e254a5-0329-2dda-e063-6294a90aa082
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethosuximide
Dosage form SOLUTION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA040506
Marketing category ANDA
Marketing start 2003-12-22
Substance ETHOSUXIMIDE
Active strength 250 mg/5mL
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 A040506-001 ETHOSUXIMIDE ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040506-001 AA
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 · 43 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 2026-09-14 22:38:34 2026-08 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040506-001 ETHOSUXIMIDE 250MG/5ML SYRUP / ORAL AA 2003-12-22 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ethosuximide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHOSUXIMIDE 250 mg/5mL
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 251322 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 62135-064-47 Ethosuximide 473 mL in 1 BOTTLE SOLUTION 473 1
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 62135-064-47 62135006447 473 mL in 1 BOTTLE (62135-064-47) 473 ml 2026-05-20 No No Current