FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
64725-0137
11-digit product format
647250137
Labeler code
64725
Product ID
64725-0137_b3b282db-b87e-456f-9c71-3f13d2e1ddb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA077802
Marketing category
ANDA
Marketing start
2007-10-09
Marketing end
0000-00-00
Substance
OXCARBAZEPINE
Active strength
150 mg/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
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0137-12019-11-27C16284748780-19855e2a2-4386-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Oxcarbazepine Tablets safely and effectively. See full prescribing information for Oxcarbazepine Tablets. Oxcarbazepine Tablets Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0137-1Oxcarbazepine100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0137OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140901_654d6aac-f7bf-4404-921c-5b8470c9064a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN654d6aac-f7bf-4404-921c-5b8470c9064a2
312136oxcarbazepine 150 MG Oral TabletSCD654d6aac-f7bf-4404-921c-5b8470c9064a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0137-164725013701100 in 1 BOTTLEHistorical