FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
68788-7866
11-digit product format
687887866
Labeler code
68788
Product ID
68788-7866_549f1700-86c6-4e21-9391-08de6ef3cbf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078069
Marketing category
ANDA
Marketing start
2021-02-15
Substance
OXCARBAZEPINE
Active strength
600 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
OXCARBAZEPINE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312138

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
68788-7866-3OXCARBAZEPINE30 in 1 BOTTLETABLET, FILM COATED306
68788-7866-6OXCARBAZEPINE60 in 1 BOTTLETABLET, FILM COATED606
68788-7866-9OXCARBAZEPINE90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7866-3EA - Each68788-78666080c335-c998-487b-9f23-b067caf2a72412021-03-02
68788-7866-6EA - Each68788-7866b684a570-a887-49d3-9a5c-f3546dab714012021-03-02
68788-7866-9EA - Each68788-78667cffc8a9-abcd-41c1-9d41-c18c6cd2421712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7866OXCARBAZEPINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20240727_e156339c-f79e-4a20-b9da-f50bea948213.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312138OXcarbazepine 600 MG Oral TabletPSNe156339c-f79e-4a20-b9da-f50bea9482136
312138oxcarbazepine 600 MG Oral TabletSCDe156339c-f79e-4a20-b9da-f50bea9482136

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7866-36878878660330 TABLET, FILM COATED in 1 BOTTLE (68788-7866-3) 2021-02-150000-00-00NoNoCurrent
68788-7866-66878878660660 TABLET, FILM COATED in 1 BOTTLE (68788-7866-6) 2021-02-150000-00-00NoNoCurrent
68788-7866-96878878660990 TABLET, FILM COATED in 1 BOTTLE (68788-7866-9) 2021-02-150000-00-00NoNoCurrent