Ethosuximide

Product NDC
63629-8005
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ethosuximide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETHOSUXIMIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5SEH9X1D1D
Rxcui197682

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dcc989c7-4ccb-d599-44b3-233abc5285bbProduct name320200708

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-8005-12024-05-14C16284748780-11030e365-3475-111a-e063-dadaa90a10e2Ethosuximide Capsules, USP Rx only
63629-8005-12024-01-30C16284748780-11030e365-3475-111a-e063-dadaa90a10e2Ethosuximide Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8005-1Ethosuximide90 in 1 BOTTLECAPSULE, LIQUID FILLED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8005ETHOSUXIMIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 1 package rows20240515_867b54c4-4ce4-4c00-a03b-f108f1000e29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197682ethosuximide 250 MG Oral CapsulePSN867b54c4-4ce4-4c00-a03b-f108f1000e293
197682ethosuximide 250 MG Oral CapsuleSCD867b54c4-4ce4-4c00-a03b-f108f1000e293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8005-16362980050190 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8005-1) 2019-05-090000-00-00NoNoCurrent