FDA.reportPublic FDA data

oxcarbazepine

Product NDC
68382-693
11-digit product format
683820693
Labeler code
68382
Product ID
68382-693_f743cc83-a47d-4a48-8be5-516be5c7d7e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxcarbazepine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA211747
Marketing category
ANDA
Marketing start
2025-07-10
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380

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
68382-693-01oxcarbazepine100 in 1 BOTTLETABLET1004
68382-693-05oxcarbazepine500 in 1 BOTTLETABLET5004
68382-693-30oxcarbazepine10 in 1 BLISTER PACKTABLET104
68382-693-30oxcarbazepine10 in 1 CARTONTABLET104

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN5048dc87-2d89-434d-be51-4a97b0ce06014
312137OXcarbazepine 300 MG Oral TabletPSN5048dc87-2d89-434d-be51-4a97b0ce06014
312138OXcarbazepine 600 MG Oral TabletPSN5048dc87-2d89-434d-be51-4a97b0ce06014
312136oxcarbazepine 150 MG Oral TabletSCD5048dc87-2d89-434d-be51-4a97b0ce06014
312137oxcarbazepine 300 MG Oral TabletSCD5048dc87-2d89-434d-be51-4a97b0ce06014
312138oxcarbazepine 600 MG Oral TabletSCD5048dc87-2d89-434d-be51-4a97b0ce06014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68382-693-0168382069301100 TABLET in 1 BOTTLE (68382-693-01) 100 tablet2025-07-10NoNoCurrent
68382-693-0568382069305500 TABLET in 1 BOTTLE (68382-693-05) 500 tablet2025-07-10NoNoCurrent
68382-693-306838206933010 BLISTER PACK in 1 CARTON (68382-693-30) / 10 TABLET in 1 BLISTER PACK10 blister pack2025-07-10NoNoCurrent