FDA.reportPublic FDA data

Eslicarbazepine Acetate

Product NDC
51407-781
11-digit product format
514070781
Labeler code
51407
Product ID
51407-781_3a3b1707-eff5-0b9a-e063-6394a90ab0a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eslicarbazepine Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA211236
Marketing category
ANDA
Marketing start
2023-12-07
Substance
ESLICARBAZEPINE ACETATE
Active strength
600 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 ACETATE600 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
51407-781-60Eslicarbazepine Acetate60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-781-60EA - Each51407-781aa38435e-304f-4130-8df2-38654f39591912025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482507eslicarbazepine acetate 200 MG Oral TabletPSN3a3b3e50-6590-0040-e063-6294a90a84c11
1482515eslicarbazepine acetate 400 MG Oral TabletPSN3a3b3e50-6590-0040-e063-6294a90a84c11
1482521eslicarbazepine acetate 600 MG Oral TabletPSN3a3b3e50-6590-0040-e063-6294a90a84c11
1482525eslicarbazepine acetate 800 MG Oral TabletPSN3a3b3e50-6590-0040-e063-6294a90a84c11
1482507eslicarbazepine acetate 200 MG Oral TabletSCD3a3b3e50-6590-0040-e063-6294a90a84c11
1482515eslicarbazepine acetate 400 MG Oral TabletSCD3a3b3e50-6590-0040-e063-6294a90a84c11
1482521eslicarbazepine acetate 600 MG Oral TabletSCD3a3b3e50-6590-0040-e063-6294a90a84c11
1482525eslicarbazepine acetate 800 MG Oral TabletSCD3a3b3e50-6590-0040-e063-6294a90a84c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-781-605140707816060 TABLET in 1 BOTTLE (51407-781-60) 60 tablet2025-05-12NoNoHistorical