FDA.reportPublic FDA data

NDC 63402-204-17 - Aptiom

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63402-204
Requested NDC
63402-204-17
Package NDCs from labels
63402-204-30, 63402-204-07, 63402-204-28, 63402-204-17
Manufacturer
Sumitomo Pharma America, Inc.
Effective date
2023-11-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aptiom - Sumitomo Pharma America, Inc.Sumitomo Pharma America, Inc.2023-11-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63402-204-07Aptiom7 in 1 BLISTER PACKTABLET716
63402-204-17Aptiom7 in 1 BLISTER PACKTABLET7400 mg16
63402-204-28Aptiom4 in 1 CARTONTABLET416
63402-204-30Aptiom30 in 1 BOTTLETABLET3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63402-204APTIOM (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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESLICARBAZEPINE ACETATEESLICARBAZEPINE ACETATEAurobindo Pharma Limited2067fb77-9657-44da-b430-02e8a4efacb52026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 1482525
rxcui: 1482515
rxcui: 1482521
rxcui: 1482507
unii: BEA68ZVB2K
Eslicarbazepine AcetateESLICARBAZEPINE ACETATEJubilant Cadista Pharmaceuticals Inc.22d08671-ac0d-4e3d-8195-929bbb0211252026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 1482525
rxcui: 1482515
rxcui: 1482521
rxcui: 1482507
unii: BEA68ZVB2K
Eslicarbazepine acetateESLICARBAZEPINE ACETATETorrent Pharmaceuticals Limitedd279e461-2611-4f5c-938d-5d117612894f2025-07-30Warnings, Adverse reactionsExact identifier
rxcui: 1482525
rxcui: 1482515
rxcui: 1482521
rxcui: 1482507
unii: BEA68ZVB2K
Eslicarbazepine AcetateESLICARBAZEPINE ACETATEGolden State Medical Supply, Inc.3a3b3e50-6590-0040-e063-6294a90a84c12025-07-18Warnings, Adverse reactionsExact identifier
rxcui: 1482525
rxcui: 1482515
rxcui: 1482521
rxcui: 1482507
unii: BEA68ZVB2K
Eslicarbazepine acetateESLICARBAZEPINE ACETATECamber Pharmaceuticals, Inc.6200ae2e-ac4e-41b6-a1c3-0ea00703d7e32025-05-23Warnings, Adverse reactionsExact identifier
rxcui: 1482525
rxcui: 1482515
rxcui: 1482521
rxcui: 1482507
unii: BEA68ZVB2K
Eslicarbazepine AcetateESLICARBAZEPINE ACETATELupin Pharmaceuticals, Inc.999b341f-fe13-4dd9-bb95-9b0d6a817c4c2025-05-07Warnings, Adverse reactionsExact identifier
rxcui: 1482525
rxcui: 1482515
rxcui: 1482521
rxcui: 1482507
unii: BEA68ZVB2K
Eslicarbazepine AcetateESLICARBAZEPINE ACETATEAscend Laboratories, LLC28efe9d2-9d7b-4a7c-8458-098456d066042025-04-14Warnings, Adverse reactionsExact identifier
rxcui: 1482525
rxcui: 1482515
rxcui: 1482521
rxcui: 1482507
unii: BEA68ZVB2K
Eslicarbazepine AcetateESLICARBAZEPINE ACETATEDr.Reddys Laboratories Inc190fccbc-da3f-b175-ac02-f2c4307a15c32025-01-30Warnings, Adverse reactionsExact identifier
rxcui: 1482525
rxcui: 1482515
rxcui: 1482521
rxcui: 1482507
unii: BEA68ZVB2K
AptiomESLICARBAZEPINE ACETATESumitomo Pharma America, Inc.3d0c9554-eaeb-4694-8089-00133fcadce32023-11-10Warnings, Adverse reactionsExact identifier
application number: NDA022416
ndc (package): 63402-208-17
ndc (package): 63402-204-17
ndc (package): 63402-204-07
ndc (package): 63402-206-60
ndc (package): 63402-204-30
ndc (package): 63402-202-30
ndc (package): 63402-208-28
ndc (package): 63402-202-28
ndc (package): 63402-208-30
ndc (package): 63402-206-28
ndc (package): 63402-204-28
ndc (package): 63402-206-07
ndc (package): 63402-208-07
ndc (package): 63402-248-56
ndc (package): 63402-202-07
ndc (package): 63402-248-14
ndc (product): 63402-248
ndc (product): 63402-208
ndc (product): 63402-204
ndc (product): 63402-202
ndc (product): 63402-206
ndc11 (package): 63402020417
rxcui: 1482517
rxcui: 1482523
rxcui: 1491643
rxcui: 1482525
rxcui: 1482527
rxcui: 1482515
rxcui: 1482521
rxcui: 1482507
rxcui: 1491642
rxcui: 1482513
spl id: 3af99c5d-50e2-4336-8a5e-e93b6cf3618a
spl set id: 3d0c9554-eaeb-4694-8089-00133fcadce3
unii: BEA68ZVB2K

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.