ETHOSUXIMIDE

Product NDC
64380-878
11-digit product format
643800878
Labeler code
64380
Product ID
64380-878_7388c216-3de2-4c6d-843c-f2e3b515a611
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETHOSUXIMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA211928
Marketing category
ANDA
Marketing start
2019-05-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-878-06ETHOSUXIMIDE100 in 1 BOTTLECAPSULE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-878-06EA - Each64380-878cc2da505-e3e1-4982-9414-dcff776cb4f112020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-878ETHOSUXIMIDE CAPSULE [STRIDES PHARMA SCIENCE LIMITED]8Current NDC, Legacy NDC, 1 package rows20250313_a4dbc665-4db1-4d0a-9630-5cd200ec4c82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197682ethosuximide 250 MG Oral CapsulePSNa4dbc665-4db1-4d0a-9630-5cd200ec4c828
197682ethosuximide 250 MG Oral CapsuleSCDa4dbc665-4db1-4d0a-9630-5cd200ec4c828

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-878-0664380087806100 CAPSULE in 1 BOTTLE (64380-878-06) 100 capsule2019-05-150000-00-00NoNoCurrent