Oxcarbazepine

Product NDC
67046-1640
11-digit product format
670461640
Labeler code
67046
Product ID
67046-1640_47b9209b-398e-1d7a-e063-6394a90a4adc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA078005
Marketing category
ANDA
Marketing start
2026-01-06
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
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
OXCARBAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312137

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
67046-1640-3Oxcarbazepine30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312137OXcarbazepine 300 MG Oral TabletPSN47b92168-6832-1e0b-e063-6394a90a079a1
312137oxcarbazepine 300 MG Oral TabletSCD47b92168-6832-1e0b-e063-6394a90a079a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1640-36704616400330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1640-3) 2026-01-06NoNoHistorical