OXCARBAZEPINE

Product NDC
72189-339
11-digit product format
721890339
Labeler code
72189
Product ID
72189-339_2c4c3e43-2d44-28b3-e063-6394a90a306a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRx
Application
ANDA077794
Marketing category
ANDA
Marketing start
2022-04-05
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

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
72189-339-60OXCARBAZEPINE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-339-60EA - Each72189-339ad175e47-9fd8-4ddc-8c02-e05117c7a2ab12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-339OXCARBAZEPINE TABLET, FILM COATED [DIRECTRX]2Current NDC, Legacy NDC, 1 package rows20250123_dbea45c2-e166-b557-e053-2995a90a7643.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSNdbea45c2-e166-b557-e053-2995a90a76432
312136oxcarbazepine 150 MG Oral TabletSCDdbea45c2-e166-b557-e053-2995a90a76432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-339-607218903396060 TABLET, FILM COATED in 1 BOTTLE (72189-339-60) 2022-04-050000-00-00NoNoCurrent