FDA.reportPublic FDA data

Eslicarbazepine Acetate

Product NDC
60505-4658
11-digit product format
605054658
Labeler code
60505
Product ID
60505-4658_34bede3a-5e85-4291-a95a-3e4d752e89f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eslicarbazepine Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA211236
Marketing category
ANDA
Marketing start
2025-05-06
Substance
ESLICARBAZEPINE ACETATE
Active strength
200 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 ACETATE200 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
60505-4658-3Eslicarbazepine Acetate30 in 1 BOTTLETABLET302
60505-4658-9Eslicarbazepine Acetate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4658-3EA - Each60505-4658fb6b88b7-1ea6-486c-9a8c-3c44c51ef7a512025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4658ESLICARBAZEPINE ACETATE TABLET [APOTEX CORP.]2Current NDC, 2 package rows20250507_22f29752-614f-caaf-b595-9deae8a3e3ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482507eslicarbazepine acetate 200 MG Oral TabletPSN22f29752-614f-caaf-b595-9deae8a3e3ff2
1482515eslicarbazepine acetate 400 MG Oral TabletPSN22f29752-614f-caaf-b595-9deae8a3e3ff2
1482521eslicarbazepine acetate 600 MG Oral TabletPSN22f29752-614f-caaf-b595-9deae8a3e3ff2
1482525eslicarbazepine acetate 800 MG Oral TabletPSN22f29752-614f-caaf-b595-9deae8a3e3ff2
1482507eslicarbazepine acetate 200 MG Oral TabletSCD22f29752-614f-caaf-b595-9deae8a3e3ff2
1482515eslicarbazepine acetate 400 MG Oral TabletSCD22f29752-614f-caaf-b595-9deae8a3e3ff2
1482521eslicarbazepine acetate 600 MG Oral TabletSCD22f29752-614f-caaf-b595-9deae8a3e3ff2
1482525eslicarbazepine acetate 800 MG Oral TabletSCD22f29752-614f-caaf-b595-9deae8a3e3ff2
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
60505-4658-36050546580330 TABLET in 1 BOTTLE (60505-4658-3) 30 tablet2025-05-06NoNoHistorical
60505-4658-96050546580990 TABLET in 1 BOTTLE (60505-4658-9) 90 tablet2025-05-06NoNoHistorical