FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
63629-3816
11-digit product format
636293816
Labeler code
63629
Product ID
63629-3816_e1e371c0-49d4-401e-8e7c-b953f579480e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078069
Marketing category
ANDA
Marketing start
2008-01-11
Substance
OXCARBAZEPINE
Active strength
150 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
OXCARBAZEPINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312136

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
63629-3816-12020-10-16C16284748780-19d75b9d0-7ea3-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 film-coated tablets, for oral use Initial U.S. Approval: 2000
63629-3816-22020-10-16C16284748780-19d75b9d0-7ea3-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 film-coated tablets, for oral use Initial U.S. Approval: 2000
63629-3816-32020-10-16C16284748780-19d75b9d0-7ea3-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 film-coated tablets, for oral use Initial U.S. Approval: 2000
63629-3816-12020-01-31C16284748780-19d75b9d0-7ea3-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 film-coated tablets, for oral use Initial U.S. Approval: 2000
63629-3816-22020-01-31C16284748780-19d75b9d0-7ea3-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 film-coated tablets, for oral use Initial U.S. Approval: 2000
63629-3816-32020-01-31C16284748780-19d75b9d0-7ea3-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 film-coated tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-3816-1OXCARBAZEPINE30 in 1 BOTTLETABLET, FILM COATED301007
63629-3816-2OXCARBAZEPINE60 in 1 BOTTLETABLET, FILM COATED601007
63629-3816-3OXCARBAZEPINE90 in 1 BOTTLETABLET, FILM COATED901007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3816-1EA - Each63629-38166e0582bb-a1f4-400c-99f1-7279cd20f14512013-02-13
63629-3816-2EA - Each63629-3816ead77141-e4bf-41b6-9ef3-9a0d73512f6012013-02-13
63629-3816-3EA - Each63629-3816cb88bdb8-1b3e-4b47-b45c-db5a8635f77812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MOXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UOXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3816OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1007Current NDC, Legacy NDC, 3 package rows20240511_78f196d4-110e-45b1-813a-725f52c1a4eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN78f196d4-110e-45b1-813a-725f52c1a4eb1007
312136oxcarbazepine 150 MG Oral TabletSCD78f196d4-110e-45b1-813a-725f52c1a4eb1007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-3816-16362938160130 TABLET, FILM COATED in 1 BOTTLE (63629-3816-1) 2011-07-280000-00-00NoNoCurrent
63629-3816-26362938160260 TABLET, FILM COATED in 1 BOTTLE (63629-3816-2) 2008-10-140000-00-00NoNoCurrent
63629-3816-36362938160390 TABLET, FILM COATED in 1 BOTTLE (63629-3816-3) 2012-08-060000-00-00NoNoCurrent