FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
63629-6834
11-digit product format
636296834
Labeler code
63629
Product ID
63629-6834_ad785cbb-ae12-4261-9fb2-a86b8735606d
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
600 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
OXCARBAZEPINE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312138

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
63629-6834-12024-05-16C16284748780-19d75b9d0-9664-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
63629-6834-22024-05-16C16284748780-19d75b9d0-9664-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
63629-6834-32024-05-16C16284748780-19d75b9d0-9664-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
63629-6834-12024-01-30C16284748780-19d75b9d0-9664-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
63629-6834-22024-01-30C16284748780-19d75b9d0-9664-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
63629-6834-32024-01-30C16284748780-19d75b9d0-9664-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
63629-6834-12020-10-16C16284748780-19d75b9d0-9664-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
63629-6834-22020-10-16C16284748780-19d75b9d0-9664-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
63629-6834-32020-10-16C16284748780-19d75b9d0-9664-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
63629-6834-12020-01-31C16284748780-19d75b9d0-9664-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
63629-6834-22020-01-31C16284748780-19d75b9d0-9664-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
63629-6834-32020-01-31C16284748780-19d75b9d0-9664-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
63629-6834-1OXCARBAZEPINE30 in 1 BOTTLETABLET, FILM COATED309
63629-6834-2OXCARBAZEPINE60 in 1 BOTTLETABLET, FILM COATED609
63629-6834-3OXCARBAZEPINE90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-6834-2EA - Each63629-68344d6a42ed-2f83-4567-b98f-b4f128a8ca7c12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-6834OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 3 package rows20240517_d3c7a3b8-b9a2-4a5f-98b3-0ed02eca3433.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312138OXcarbazepine 600 MG Oral TabletPSNd3c7a3b8-b9a2-4a5f-98b3-0ed02eca34339
312138oxcarbazepine 600 MG Oral TabletSCDd3c7a3b8-b9a2-4a5f-98b3-0ed02eca34339

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-6834-16362968340130 TABLET, FILM COATED in 1 BOTTLE (63629-6834-1) 2016-06-270000-00-00NoNoCurrent
63629-6834-26362968340260 TABLET, FILM COATED in 1 BOTTLE (63629-6834-2) 2015-11-020000-00-00NoNoCurrent
63629-6834-36362968340390 TABLET, FILM COATED in 1 BOTTLE (63629-6834-3) 2016-07-130000-00-00NoNoCurrent