FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
50268-680
11-digit product format
502680680
Labeler code
50268
Product ID
50268-680_2b4c161c-f20b-38d5-e063-6394a90a8a79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA215939
Marketing category
ANDA
Marketing start
2023-06-07
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-680-11Oxcarbazepine1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-680-15Oxcarbazepine50 in 1 BOXTABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-680-11EA - Each50268-680df8b84ea-062f-4d4c-966c-5af2dfc568c812023-07-06
50268-680-15EA - Each50268-680a97703b8-8018-4ee3-a66e-d64a581e5f3d12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-680OXCARBAZEPINE TABLET, FILM COATED [AVPAK]2Current NDC, 2 package rows20250112_fd8da0e9-d69b-7587-e053-6294a90a33c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSNfd8da0e9-d69b-7587-e053-6294a90a33c02
312137OXcarbazepine 300 MG Oral TabletPSNfd8da0e9-d69b-7587-e053-6294a90a33c02
312138OXcarbazepine 600 MG Oral TabletPSNfd8da0e9-d69b-7587-e053-6294a90a33c02
312136oxcarbazepine 150 MG Oral TabletSCDfd8da0e9-d69b-7587-e053-6294a90a33c02
312137oxcarbazepine 300 MG Oral TabletSCDfd8da0e9-d69b-7587-e053-6294a90a33c02
312138oxcarbazepine 600 MG Oral TabletSCDfd8da0e9-d69b-7587-e053-6294a90a33c02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-680-11502680680111 in 1 BLISTER PACKHistorical
50268-680-155026806801550 BLISTER PACK in 1 BOX (50268-680-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-680-11) 50 blister pack2023-06-07NoNoCurrent