FDA.reportPublic FDA data

Eslicarbazepine Acetate

Product NDC
43598-687
11-digit product format
435980687
Labeler code
43598
Product ID
43598-687_75484338-6d78-877c-086f-61467c8dd5e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eslicarbazepine Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA211238
Marketing category
ANDA
Marketing start
2025-05-06
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
Eslicarbazepine Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESLICARBAZEPINE ACETATE800 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
43598-687-30Eslicarbazepine Acetate30 in 1 BOTTLETABLET304
43598-687-90Eslicarbazepine Acetate90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-687-30EA - Each43598-687b0337576-7615-4aec-b55b-5a5a1ddd019e12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-687ESLICARBAZEPINE ACETATE TABLET [DR.REDDYS LABORATORIES INC]4Current NDC, 2 package rows20250507_190fccbc-da3f-b175-ac02-f2c4307a15c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482507eslicarbazepine acetate 200 MG Oral TabletPSN190fccbc-da3f-b175-ac02-f2c4307a15c34
1482515eslicarbazepine acetate 400 MG Oral TabletPSN190fccbc-da3f-b175-ac02-f2c4307a15c34
1482521eslicarbazepine acetate 600 MG Oral TabletPSN190fccbc-da3f-b175-ac02-f2c4307a15c34
1482525eslicarbazepine acetate 800 MG Oral TabletPSN190fccbc-da3f-b175-ac02-f2c4307a15c34
1482507eslicarbazepine acetate 200 MG Oral TabletSCD190fccbc-da3f-b175-ac02-f2c4307a15c34
1482515eslicarbazepine acetate 400 MG Oral TabletSCD190fccbc-da3f-b175-ac02-f2c4307a15c34
1482521eslicarbazepine acetate 600 MG Oral TabletSCD190fccbc-da3f-b175-ac02-f2c4307a15c34
1482525eslicarbazepine acetate 800 MG Oral TabletSCD190fccbc-da3f-b175-ac02-f2c4307a15c34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-687-304359806873030 TABLET in 1 BOTTLE (43598-687-30) 30 tablet2025-05-06NoNoCurrent
43598-687-904359806879090 TABLET in 1 BOTTLE (43598-687-90) 90 tablet2025-05-06NoNoCurrent