FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
70518-3237
11-digit product format
705183237
Labeler code
70518
Product ID
70518-3237_4b04e14b-81c3-42d7-e063-6394a90aaeaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077802
Marketing category
ANDA
Marketing start
2021-10-13
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
70518-3237-02023-03-22C16284748780-1f386c649-bfb9-0266-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 tablets, for oral use Initial U.S. Approval: 2000
70518-3237-02023-03-22C16284748780-1f386c649-bfb9-0266-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 tablets, for oral use Initial U.S. Approval: 2000
70518-3237-02023-01-30C16284748780-1f386c649-bfb9-0266-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 tablets, for oral use Initial U.S. Approval: 2000
70518-3237-02023-01-30C16284748780-1f386c649-bfb9-0266-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 tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3237-0Oxcarbazepine100 in 1 BOXTABLET, FILM COATED1008
70518-3237-1Oxcarbazepine1 in 1 POUCHTABLET, FILM COATED18
70518-3237-2Oxcarbazepine30 in 1 BLISTER PACKTABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3237OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250215_a2032bcc-2da5-45e5-aa3f-ddbf50909df8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312137OXcarbazepine 300 MG Oral TabletPSNa2032bcc-2da5-45e5-aa3f-ddbf50909df88
312137oxcarbazepine 300 MG Oral TabletSCDa2032bcc-2da5-45e5-aa3f-ddbf50909df88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3237-070518323700100 POUCH in 1 BOX (70518-3237-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3237-1) 100 pouch2021-10-130000-00-00NoNoCurrent
70518-3237-1705183237011 in 1 POUCHHistorical
70518-3237-27051832370230 TABLET, FILM COATED in 1 BLISTER PACK (70518-3237-2) 2025-02-11NoNoCurrent