FDA.reportPublic FDA data

OXTELLAR XR

Product NDC
17772-121
11-digit product format
177720121
Labeler code
17772
Product ID
17772-121_41c1a4d4-ff5a-00b4-e063-6294a90a6ec7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
Supernus Pharmaceuticals, Inc.
Application
NDA202810
Marketing category
NDA
Marketing start
2013-01-17
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
OXTELLAR XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui1365653, 1365660, 1365842, 1365844, 1365847, 1365850

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17772-121-012025-08-15C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-012025-08-15C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-072025-08-15C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-072025-08-15C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-102025-08-15C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-102025-08-15C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-012025-07-29C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-012025-07-29C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-072025-07-29C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-072025-07-29C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-102025-07-29C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-121-102025-07-29C16284748780-13b156c62-2af2-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17772-121-01OXTELLAR XR100 in 1 BOTTLETABLET10021
17772-121-07OXTELLAR XR7 in 1 BOTTLETABLET721
17772-121-10OXTELLAR XR5 in 1 BLISTER PACKTABLET521

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17772-121-01EA - Each17772-12188df20b3-8fbb-46f7-b88a-3161c666e27712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
POLYETHYLENE GLYCOL 2000INACTIVE INGREDIENTHAF0412YITOXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
TALCINACTIVE INGREDIENT7SEV7J4R1UOXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17772-121OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 3 package rows20241013_aa610e56-1d1d-11e1-8bc2-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365653OXcarbazepine 150 MG 24HR Extended Release Oral TabletPSNaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365842OXcarbazepine 300 MG 24HR Extended Release Oral TabletPSNaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365844OXcarbazepine 600 MG 24HR Extended Release Oral TabletPSNaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365660Oxtellar XR 150 MG 24HR Extended Release Oral Tablet, Once-DailyPSNaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365847Oxtellar XR 300 MG 24HR Extended Release Oral Tablet, Once-DailyPSNaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365850Oxtellar XR 600 MG 24HR Extended Release Oral Tablet, Once-DailyPSNaa610e56-1d1d-11e1-8bc2-0800200c9a6621
136566024 HR oxcarbazepine 150 MG Extended Release Oral Tablet [Oxtellar]SBDaa610e56-1d1d-11e1-8bc2-0800200c9a6621
136584724 HR oxcarbazepine 300 MG Extended Release Oral Tablet [Oxtellar]SBDaa610e56-1d1d-11e1-8bc2-0800200c9a6621
136585024 HR oxcarbazepine 600 MG Extended Release Oral Tablet [Oxtellar]SBDaa610e56-1d1d-11e1-8bc2-0800200c9a6621
136565324 HR oxcarbazepine 150 MG Extended Release Oral TabletSCDaa610e56-1d1d-11e1-8bc2-0800200c9a6621
136584224 HR oxcarbazepine 300 MG Extended Release Oral TabletSCDaa610e56-1d1d-11e1-8bc2-0800200c9a6621
136584424 HR oxcarbazepine 600 MG Extended Release Oral TabletSCDaa610e56-1d1d-11e1-8bc2-0800200c9a6621
136566024 HR Oxtellar 150 MG Extended Release Oral TabletSYaa610e56-1d1d-11e1-8bc2-0800200c9a6621
136584724 HR Oxtellar 300 MG Extended Release Oral TabletSYaa610e56-1d1d-11e1-8bc2-0800200c9a6621
136585024 HR Oxtellar 600 MG Extended Release Oral TabletSYaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365653oxcarbazepine 150 MG 24 HR Extended Release Oral TabletSYaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365842oxcarbazepine 300 MG 24 HR Extended Release Oral TabletSYaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365844oxcarbazepine 600 MG 24 HR Extended Release Oral TabletSYaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365660Oxtellar XR 150 MG 24 HR Extended Release Oral TabletSYaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365847Oxtellar XR 300 MG 24 HR Extended Release Oral TabletSYaa610e56-1d1d-11e1-8bc2-0800200c9a6621
1365850Oxtellar XR 600 MG 24 HR Extended Release Oral TabletSYaa610e56-1d1d-11e1-8bc2-0800200c9a6621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17772-121-0117772012101100 TABLET in 1 BOTTLE (17772-121-01) 100 tablet2013-01-170000-00-00NoNoCurrent
17772-121-07177720121077 TABLET in 1 BOTTLE (17772-121-07) 7 tablet2023-07-01YesNoCurrent
17772-121-10177720121105 TABLET in 1 BLISTER PACK (17772-121-10) 5 tablet2013-01-170000-00-00YesNoCurrent