FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
64725-0292
11-digit product format
647250292
Labeler code
64725
Product ID
64725-0292_885b029e-8ee6-4aa6-acf9-338058069e3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA078069
Marketing category
ANDA
Marketing start
2008-01-11
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
64725-0292-12020-01-31C16284748780-19d75b9cf-e1e3-f424-e053-dadaa90a57ceThese 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
64725-0292-1OXCARBAZEPINE100 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
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1UOXCARBAZEPINE 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
64725-0292OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141110_6b4f9f7b-b48a-4dfd-bff5-9405cb38eff2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN6b4f9f7b-b48a-4dfd-bff5-9405cb38eff22
312136oxcarbazepine 150 MG Oral TabletSCD6b4f9f7b-b48a-4dfd-bff5-9405cb38eff22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0292-164725029201100 in 1 BOTTLEHistorical