Home NDC 42806-711-01 Ethosuximide
Product NDC 42806-711
Requested package NDC 42806-711-01
11-digit product format 428060711
Labeler code 42806
Product ID 42806-711_2b366128-2db7-bb4e-e063-6294a90af2d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ethosuximide
Dosage form CAPSULE
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA210654
Marketing category ANDA
Marketing start 2020-03-16
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 1 .
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 2026-08-01 22:54:32 2026-06 A210654-001 ETHOSUXIMIDE 250MG CAPSULE / ORAL AB 2020-03-16 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A210654-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 42806-711-01 Ethosuximide 100 in 1 BOTTLE CAPSULE 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-711 ETHOSUXIMIDE CAPSULE [EPIC PHARMA, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20250110_a040dab2-0d70-4c02-a830-5ba1e3506a1b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42806-711-01 42806071101 100 CAPSULE in 1 BOTTLE (42806-711-01) 100 capsule 2020-04-15 0000-00-00 No No Current