ethosuximide

Product NDC
68382-443
11-digit product format
683820443
Labeler code
68382
Product ID
68382-443_f4d37571-27b3-4d2b-a211-c21491d75718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ethosuximide
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA200892
Marketing category
ANDA
Marketing start
2012-10-10
Marketing end
0000-00-00
Substance
ETHOSUXIMIDE
Active strength
250 1/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68382-443-012019-11-13C16284748780-197449f38-cccb-f6ea-e053-dbdaa90aa703Ethosuximide Capsules,USP
68382-443-052019-11-13C16284748780-197449f38-cccb-f6ea-e053-dbdaa90aa703Ethosuximide Capsules,USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-443-01ethosuximide100 in 1 BOTTLECAPSULE1001
68382-443-05ethosuximide500 in 1 BOTTLECAPSULE5001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHOSUXIMIDEACTIVE INGREDIENT5SEH9X1D1DETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
ETHOSUXIMIDEACTIVE MOIETY5SEH9X1D1DETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
GELATININACTIVE INGREDIENT2G86QN327LETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-443ETHOSUXIMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]1Legacy NDC, 2 package rows20121010_cb5577e2-e906-438f-b13d-e55709a0e7fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197682ethosuximide 250 MG Oral CapsulePSNcb5577e2-e906-438f-b13d-e55709a0e7fd1
197682ethosuximide 250 MG Oral CapsuleSCDcb5577e2-e906-438f-b13d-e55709a0e7fd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68382-443-0168382044301100 in 1 BOTTLEHistorical
68382-443-0568382044305500 in 1 BOTTLEHistorical