OXCARBAZEPINE

Product NDC
70518-2276
11-digit product format
705182276
Labeler code
70518
Product ID
70518-2276_49f0ac09-d5f1-4bc2-e063-6294a90a8319
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078069
Marketing category
ANDA
Marketing start
2019-08-22
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2276-0OXCARBAZEPINE30 in 1 BLISTER PACKTABLET, FILM COATED3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2276OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 1 package rows20250508_6d2a6cac-f16b-4e6c-8f75-3afffb0a0f3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312137OXcarbazepine 300 MG Oral TabletPSN6d2a6cac-f16b-4e6c-8f75-3afffb0a0f3b12
312137oxcarbazepine 300 MG Oral TabletSCD6d2a6cac-f16b-4e6c-8f75-3afffb0a0f3b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2276-07051822760030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2276-0) 2019-08-220000-00-00NoNoCurrent