Ethosuximide

Product NDC
61748-025
11-digit product format
617480025
Labeler code
61748
Product ID
61748-025_61032dd5-2391-4dd0-9899-7909e2ea4e1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethosuximide
Dosage form
CAPSULE
Route
ORAL
Labeler
Akorn
Application
ANDA040686
Marketing category
ANDA
Marketing start
2008-09-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dcc989c7-4ccb-d599-44b3-233abc5285bbProduct name320200708
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61748-025-012024-01-30C16284748780-11030e364-fe73-111a-e063-dadaa90a10e2Ethosuximide Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61748-025-01Ethosuximide100 in 1 BOTTLECAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61748-025-01EA - Each61748-025e9827fe9-9b72-4366-8e1a-de2802742b8b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHOSUXIMIDEACTIVE INGREDIENT5SEH9X1D1DETHOSUXIMIDE CAPSULE [VERSAPHARM INCORPORATED]3
ETHOSUXIMIDEACTIVE MOIETY5SEH9X1D1DETHOSUXIMIDE CAPSULE [VERSAPHARM INCORPORATED]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYETHOSUXIMIDE CAPSULE [VERSAPHARM INCORPORATED]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETHOSUXIMIDE CAPSULE [VERSAPHARM INCORPORATED]3
GELATININACTIVE INGREDIENT2G86QN327LETHOSUXIMIDE CAPSULE [VERSAPHARM INCORPORATED]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXETHOSUXIMIDE CAPSULE [VERSAPHARM INCORPORATED]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQETHOSUXIMIDE CAPSULE [VERSAPHARM INCORPORATED]3
SORBITOLINACTIVE INGREDIENT506T60A25RETHOSUXIMIDE CAPSULE [VERSAPHARM INCORPORATED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61748-025ETHOSUXIMIDE CAPSULE [AKORN]7Legacy NDC, 1 package rows20220322_01e8e8ee-b19f-4b3f-a140-9c7391393e1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197682ethosuximide 250 MG Oral CapsulePSN01e8e8ee-b19f-4b3f-a140-9c7391393e1c7
197682ethosuximide 250 MG Oral CapsuleSCD01e8e8ee-b19f-4b3f-a140-9c7391393e1c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61748-025-0161748002501100 CAPSULE in 1 BOTTLE (61748-025-01) 100 capsule2008-09-010000-00-00NoNoCurrent