FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
71335-2548
11-digit product format
713352548
Labeler code
71335
Product ID
71335-2548_99a631d2-4db5-4d59-9d54-a6334d7b9fac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215939
Marketing category
ANDA
Marketing start
2022-01-11
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
Rxcui312137

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2548-1Oxcarbazepine30 in 1 BOTTLETABLET, FILM COATED301
71335-2548-2Oxcarbazepine60 in 1 BOTTLETABLET, FILM COATED601
71335-2548-3Oxcarbazepine90 in 1 BOTTLETABLET, FILM COATED901
71335-2548-4Oxcarbazepine180 in 1 BOTTLETABLET, FILM COATED1801
71335-2548-5Oxcarbazepine120 in 1 BOTTLETABLET, FILM COATED1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2548-1EA - Each71335-254878355c9f-9b37-45cc-a2ee-b2b60c6f320012026-01-08
71335-2548-2EA - Each71335-25484040837d-26d1-418b-8983-c4f98e86599a12026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2548OXCARBAZEPINE (OXCARBAZEPINE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1Current NDC, 5 package rows20250123_23137a89-cbd0-4a5f-8220-f26b7ba54330.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312137OXcarbazepine 300 MG Oral TabletPSN23137a89-cbd0-4a5f-8220-f26b7ba543301
312137oxcarbazepine 300 MG Oral TabletSCD23137a89-cbd0-4a5f-8220-f26b7ba543301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2548-17133525480130 TABLET, FILM COATED in 1 BOTTLE (71335-2548-1) 2025-01-21NoNoHistorical
71335-2548-27133525480260 TABLET, FILM COATED in 1 BOTTLE (71335-2548-2) 2025-01-21NoNoHistorical
71335-2548-37133525480390 TABLET, FILM COATED in 1 BOTTLE (71335-2548-3) 2025-01-21NoNoHistorical
71335-2548-471335254804180 TABLET, FILM COATED in 1 BOTTLE (71335-2548-4) 2025-01-21NoNoHistorical
71335-2548-571335254805120 TABLET, FILM COATED in 1 BOTTLE (71335-2548-5) 2025-01-21NoNoHistorical