FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
70518-2370
11-digit product format
705182370
Labeler code
70518
Product ID
70518-2370_4a063c48-af90-6642-e063-6394a90addc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078069
Marketing category
ANDA
Marketing start
2019-10-19
Substance
OXCARBAZEPINE
Active strength
300 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
OXCARBAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312137

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
70518-2370-02023-03-09C16284748780-1f386c649-a013-0266-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
70518-2370-02023-01-30C16284748780-1f386c649-a013-0266-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
70518-2370-0OXCARBAZEPINE100 in 1 BOXTABLET, FILM COATED10013
70518-2370-1OXCARBAZEPINE1 in 1 POUCHTABLET, FILM COATED113
70518-2370-2OXCARBAZEPINE100 in 1 BOXTABLET, FILM COATED10013
70518-2370-3OXCARBAZEPINE1 in 1 POUCHTABLET, FILM COATED113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2370OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 4 package rows20250419_ffc8d10c-0049-4fe5-beb8-79cc6a197ede.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312137OXcarbazepine 300 MG Oral TabletPSNffc8d10c-0049-4fe5-beb8-79cc6a197ede13
312137oxcarbazepine 300 MG Oral TabletSCDffc8d10c-0049-4fe5-beb8-79cc6a197ede13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2370-070518237000100 POUCH in 1 BOX, UNIT-DOSE (70518-2370-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-2370-1) 100 pouch2019-10-190000-00-00NoNoCurrent
70518-2370-1705182370011 in 1 POUCHHistorical
70518-2370-270518237002100 POUCH in 1 BOX (70518-2370-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-2370-3) 100 pouch2024-10-04NoNoHistorical
70518-2370-3705182370031 in 1 POUCHHistorical