FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
72865-284
11-digit product format
728650284
Labeler code
72865
Product ID
72865-284_1d5c79a3-4eec-f65b-e063-6294a90aab4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA215939
Marketing category
ANDA
Marketing start
2024-07-18
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
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
OXCARBAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312136, 312137, 312138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72865-284-01Oxcarbazepine100 in 1 BOTTLETABLET, FILM COATED1001
72865-284-05Oxcarbazepine500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-284-01EA - Each72865-2842680f6db-b1e3-4c62-95a1-5e4683a865c112024-10-04
72865-284-05EA - Each72865-2848323c961-44d5-40ad-9ad1-f1ebebcdea1012024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-284OXCARBAZEPINE (OXCARBAZEPINE) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240719_9f5d17e4-ca68-48e2-9e87-d3ab1c59aa93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN9f5d17e4-ca68-48e2-9e87-d3ab1c59aa931
312137OXcarbazepine 300 MG Oral TabletPSN9f5d17e4-ca68-48e2-9e87-d3ab1c59aa931
312138OXcarbazepine 600 MG Oral TabletPSN9f5d17e4-ca68-48e2-9e87-d3ab1c59aa931
312136oxcarbazepine 150 MG Oral TabletSCD9f5d17e4-ca68-48e2-9e87-d3ab1c59aa931
312137oxcarbazepine 300 MG Oral TabletSCD9f5d17e4-ca68-48e2-9e87-d3ab1c59aa931
312138oxcarbazepine 600 MG Oral TabletSCD9f5d17e4-ca68-48e2-9e87-d3ab1c59aa931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72865-284-0172865028401100 TABLET, FILM COATED in 1 BOTTLE (72865-284-01) 2024-07-18NoNoCurrent
72865-284-0572865028405500 TABLET, FILM COATED in 1 BOTTLE (72865-284-05) 2024-07-18NoNoCurrent