FDA.reportPublic FDA data

Aptiom

Product NDC
63402-208
11-digit product format
634020208
Labeler code
63402
Product ID
63402-208_3af99c5d-50e2-4336-8a5e-e93b6cf3618a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESLICARBAZEPINE ACETATE
Dosage form
TABLET
Route
ORAL
Labeler
Sumitomo Pharma America, Inc.
Application
NDA022416
Marketing category
NDA
Marketing start
2014-04-07
Substance
ESLICARBAZEPINE ACETATE
Active strength
800 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], 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
Aptiom
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESLICARBAZEPINE ACETATE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBEA68ZVB2K
Rxcui1482507, 1482513, 1482515, 1482517, 1482521, 1482523, 1482525, 1482527, 1491642, 1491643

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d24d1d2-3014-4f74-bf96-88297667a253Product name320240906

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63402-208-07Aptiom7 in 1 BLISTER PACKTABLET716
63402-208-17Aptiom7 in 1 BLISTER PACKTABLET7800 mg16
63402-208-28Aptiom4 in 1 CARTONTABLET416
63402-208-30Aptiom30 in 1 BOTTLETABLET3016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESLICARBAZEPINE ACETATEACTIVE INGREDIENTBEA68ZVB2KAPTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUNOVION PHARMACEUTICALS INC.]6
ESLICARBAZEPINEACTIVE MOIETYS5VXA428R4APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUNOVION PHARMACEUTICALS INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUNOVION PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUNOVION PHARMACEUTICALS INC.]6
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQAPTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUNOVION PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63402-208APTIOM (ESLICARBAZEPINE ACETATE) TABLET APTIOM (ESLICARBAZEPINE ACETATE) KIT [SUMITOMO PHARMA AMERICA, INC.]16Current NDC, Legacy NDC, 3 package rows20231205_3d0c9554-eaeb-4694-8089-00133fcadce3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1491643{7 (eslicarbazepine acetate 400 MG Oral Tablet [Aptiom]) / 7 (eslicarbazepine acetate 800 MG Oral Tablet [Aptiom]) } Pack [Aptiom Titration Sample Pack]BPCK3d0c9554-eaeb-4694-8089-00133fcadce316
1491642{7 (eslicarbazepine acetate 400 MG Oral Tablet) / 7 (eslicarbazepine acetate 800 MG Oral Tablet) } PackGPCK3d0c9554-eaeb-4694-8089-00133fcadce316
1482513Aptiom 200 MG Oral Tablet, Once DailyPSN3d0c9554-eaeb-4694-8089-00133fcadce316
1482517Aptiom 400 MG Oral Tablet, Once DailyPSN3d0c9554-eaeb-4694-8089-00133fcadce316
1482523Aptiom 600 MG Oral Tablet, Once DailyPSN3d0c9554-eaeb-4694-8089-00133fcadce316
1482527Aptiom 800 MG Oral Tablet, Once DailyPSN3d0c9554-eaeb-4694-8089-00133fcadce316
1491643Aptiom Titration Sample PackPSN3d0c9554-eaeb-4694-8089-00133fcadce316
1482507eslicarbazepine acetate 200 MG Oral TabletPSN3d0c9554-eaeb-4694-8089-00133fcadce316
1491642eslicarbazepine acetate 400 MG (7) / eslicarbazepine acetate 800 MG (7) PackPSN3d0c9554-eaeb-4694-8089-00133fcadce316
1482515eslicarbazepine acetate 400 MG Oral TabletPSN3d0c9554-eaeb-4694-8089-00133fcadce316
1482521eslicarbazepine acetate 600 MG Oral TabletPSN3d0c9554-eaeb-4694-8089-00133fcadce316
1482525eslicarbazepine acetate 800 MG Oral TabletPSN3d0c9554-eaeb-4694-8089-00133fcadce316
1482513eslicarbazepine acetate 200 MG Oral Tablet [Aptiom]SBD3d0c9554-eaeb-4694-8089-00133fcadce316
1482517eslicarbazepine acetate 400 MG Oral Tablet [Aptiom]SBD3d0c9554-eaeb-4694-8089-00133fcadce316
1482523eslicarbazepine acetate 600 MG Oral Tablet [Aptiom]SBD3d0c9554-eaeb-4694-8089-00133fcadce316
1482527eslicarbazepine acetate 800 MG Oral Tablet [Aptiom]SBD3d0c9554-eaeb-4694-8089-00133fcadce316
1482507eslicarbazepine acetate 200 MG Oral TabletSCD3d0c9554-eaeb-4694-8089-00133fcadce316
1482515eslicarbazepine acetate 400 MG Oral TabletSCD3d0c9554-eaeb-4694-8089-00133fcadce316
1482521eslicarbazepine acetate 600 MG Oral TabletSCD3d0c9554-eaeb-4694-8089-00133fcadce316
1482525eslicarbazepine acetate 800 MG Oral TabletSCD3d0c9554-eaeb-4694-8089-00133fcadce316
1482513Aptiom 200 MG Oral TabletSY3d0c9554-eaeb-4694-8089-00133fcadce316
1482517Aptiom 400 MG Oral TabletSY3d0c9554-eaeb-4694-8089-00133fcadce316
1482523Aptiom 600 MG Oral TabletSY3d0c9554-eaeb-4694-8089-00133fcadce316
1482527Aptiom 800 MG Oral TabletSY3d0c9554-eaeb-4694-8089-00133fcadce316
1491643Aptiom Titration Sample PackSY3d0c9554-eaeb-4694-8089-00133fcadce316
1491642Titration Sample Pack (7 eslicarbazepine acetate 400 MG Oral Tablet / 7 eslicarbazepine acetate 800 MG Oral Tablet)SY3d0c9554-eaeb-4694-8089-00133fcadce316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63402-208-07634020208077 in 1 BLISTER PACKHistorical
63402-208-17634020208177 in 1 BLISTER PACKHistorical
63402-208-28634020208284 BLISTER PACK in 1 CARTON (63402-208-28) / 7 TABLET in 1 BLISTER PACK (63402-208-07) 4 blister pack2014-04-070000-00-00NoNoCurrent
63402-208-306340202083030 TABLET in 1 BOTTLE (63402-208-30) 30 tablet2014-04-070000-00-00NoNoCurrent