Oxcarbazepine

Product NDC
71205-411
11-digit product format
712050411
Labeler code
71205
Product ID
71205-411_0f92415d-6d81-4cc1-9a3b-028430951eb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077802
Marketing category
ANDA
Marketing start
2007-10-09
Substance
OXCARBAZEPINE
Active strength
150 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
OXCARBAZEPINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312136

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
71205-411-30Oxcarbazepine30 in 1 BOTTLETABLET, FILM COATED302
71205-411-60Oxcarbazepine60 in 1 BOTTLETABLET, FILM COATED602
71205-411-90Oxcarbazepine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-411OXCARBAZEPINE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20221111_95867dcd-fd0e-4570-987b-d35939f7d7d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN95867dcd-fd0e-4570-987b-d35939f7d7d12
312136oxcarbazepine 150 MG Oral TabletSCD95867dcd-fd0e-4570-987b-d35939f7d7d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-411-307120504113030 TABLET, FILM COATED in 1 BOTTLE (71205-411-30) 2020-02-260000-00-00NoNoCurrent
71205-411-607120504116060 TABLET, FILM COATED in 1 BOTTLE (71205-411-60) 2020-02-260000-00-00NoNoCurrent
71205-411-907120504119090 TABLET, FILM COATED in 1 BOTTLE (71205-411-90) 2020-02-260000-00-00NoNoCurrent