FDA.reportPublic FDA data

Eslicarbazepine acetate

Product NDC
13668-539
11-digit product format
136680539
Labeler code
13668
Product ID
13668-539_3b2943e4-21ea-828b-e063-6294a90a275b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eslicarbazepine acetate
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA211227
Marketing category
ANDA
Marketing start
2025-05-06
Substance
ESLICARBAZEPINE ACETATE
Active strength
400 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
Eslicarbazepine acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESLICARBAZEPINE ACETATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBEA68ZVB2K
Rxcui1482507, 1482515, 1482521, 1482525

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
13668-539-05Eslicarbazepine acetate500 in 1 BOTTLETABLET5006
13668-539-30Eslicarbazepine acetate30 in 1 BOTTLETABLET306
13668-539-60Eslicarbazepine acetate60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-539-30EA - Each13668-539f0325089-74c4-44e0-b2ed-62fbd3f3ef0912025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-539ESLICARBAZEPINE ACETATE TABLET [TORRENT PHARMACEUTICALS LIMITED]5Current NDC, 3 package rows20250507_d279e461-2611-4f5c-938d-5d117612894f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482507eslicarbazepine acetate 200 MG Oral TabletPSNd279e461-2611-4f5c-938d-5d117612894f6
1482515eslicarbazepine acetate 400 MG Oral TabletPSNd279e461-2611-4f5c-938d-5d117612894f6
1482521eslicarbazepine acetate 600 MG Oral TabletPSNd279e461-2611-4f5c-938d-5d117612894f6
1482525eslicarbazepine acetate 800 MG Oral TabletPSNd279e461-2611-4f5c-938d-5d117612894f6
1482507eslicarbazepine acetate 200 MG Oral TabletSCDd279e461-2611-4f5c-938d-5d117612894f6
1482515eslicarbazepine acetate 400 MG Oral TabletSCDd279e461-2611-4f5c-938d-5d117612894f6
1482521eslicarbazepine acetate 600 MG Oral TabletSCDd279e461-2611-4f5c-938d-5d117612894f6
1482525eslicarbazepine acetate 800 MG Oral TabletSCDd279e461-2611-4f5c-938d-5d117612894f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-539-0513668053905500 TABLET in 1 BOTTLE (13668-539-05) 500 tablet2025-05-06NoNoHistorical
13668-539-301366805393030 TABLET in 1 BOTTLE (13668-539-30) 30 tablet2025-05-06NoNoHistorical
13668-539-601366805396060 TABLET in 1 BOTTLE (13668-539-60) 60 tablet2025-05-06NoNoHistorical