Oxcarbazepine

Product NDC
67046-0179
11-digit product format
670460179
Labeler code
67046
Product ID
67046-0179_50873e5d-cba5-66bf-e063-6294a90aac28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA077802
Marketing category
ANDA
Marketing start
2026-04-28
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
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
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
67046-0179-3Oxcarbazepine30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312138OXcarbazepine 600 MG Oral TabletPSN50873ef7-3deb-7386-e063-6394a90a9c191
312138oxcarbazepine 600 MG Oral TabletSCD50873ef7-3deb-7386-e063-6394a90a9c191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-0179-36704601790330 TABLET, FILM COATED in 1 BLISTER PACK (67046-0179-3) 2026-04-28NoNoCurrent