FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
70518-2254
11-digit product format
705182254
Labeler code
70518
Product ID
70518-2254_49ef6910-c575-0379-e063-6394a90ab0d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078069
Marketing category
ANDA
Marketing start
2019-08-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OXCARBAZEPINE
Listing expiration
2027-12-31

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
70518-2254-02023-03-08C16284748780-1f386c64a-48a7-0266-e053-dadaa90a7c1aThese 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
70518-2254-02023-01-30C16284748780-1f386c64a-48a7-0266-e053-dadaa90a7c1aThese 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
70518-2254-0OXCARBAZEPINE30 in 1 BLISTER PACKTABLET, FILM COATED3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2254OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 1 package rows20250508_244f9a68-5ab4-46b8-a01f-538572fd3c5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312138OXcarbazepine 600 MG Oral TabletPSN244f9a68-5ab4-46b8-a01f-538572fd3c5f12
312138oxcarbazepine 600 MG Oral TabletSCD244f9a68-5ab4-46b8-a01f-538572fd3c5f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2254-07051822540030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2254-0) 2019-08-050000-00-00NoNoCurrent