OXCARBAZEPINE

Product NDC
55154-4323
11-digit product format
551544323
Labeler code
55154
Product ID
55154-4323_1043ad23-eb5c-4b07-8f2f-452415fbd802
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078069
Marketing category
ANDA
Marketing start
2022-11-07
Substance
OXCARBAZEPINE
Active strength
150 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
OXCARBAZEPINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312136, 312137

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
55154-4323-0OXCARBAZEPINE10 in 1 BAGTABLET, FILM COATED103
55154-4323-0OXCARBAZEPINE1 in 1 BLISTER PACKTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4323OXCARBAZEPINE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]2Current NDC, 2 package rows20241003_4ebcb0e5-1c93-4b3f-8749-6835c56afce5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN4ebcb0e5-1c93-4b3f-8749-6835c56afce53
312137OXcarbazepine 300 MG Oral TabletPSN4ebcb0e5-1c93-4b3f-8749-6835c56afce53
312136oxcarbazepine 150 MG Oral TabletSCD4ebcb0e5-1c93-4b3f-8749-6835c56afce53
312137oxcarbazepine 300 MG Oral TabletSCD4ebcb0e5-1c93-4b3f-8749-6835c56afce53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-4323-05515443230010 BLISTER PACK in 1 BAG (55154-4323-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2023-08-01NoNoCurrent