FDA.reportPublic FDA data

Eslicarbazepine acetate

Product NDC
31722-431
11-digit product format
317220431
Labeler code
31722
Product ID
31722-431_35c91221-dff8-9144-e063-6394a90a57fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eslicarbazepine acetate
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA211186
Marketing category
ANDA
Marketing start
2023-08-03
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
31722-431-30Eslicarbazepine acetate30 in 1 BOTTLETABLET302
31722-431-31Eslicarbazepine acetate10 in 1 BLISTER PACKTABLET102
31722-431-32Eslicarbazepine acetate10 in 1 CARTONTABLET102
31722-431-90Eslicarbazepine acetate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-431-30EA - Each31722-43183c62a45-3c17-403a-92b0-8ad5b3fe322c12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-431ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE) TABLET [CAMBER PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20250524_6200ae2e-ac4e-41b6-a1c3-0ea00703d7e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482507eslicarbazepine acetate 200 MG Oral TabletPSN6200ae2e-ac4e-41b6-a1c3-0ea00703d7e32
1482515eslicarbazepine acetate 400 MG Oral TabletPSN6200ae2e-ac4e-41b6-a1c3-0ea00703d7e32
1482521eslicarbazepine acetate 600 MG Oral TabletPSN6200ae2e-ac4e-41b6-a1c3-0ea00703d7e32
1482525eslicarbazepine acetate 800 MG Oral TabletPSN6200ae2e-ac4e-41b6-a1c3-0ea00703d7e32
1482507eslicarbazepine acetate 200 MG Oral TabletSCD6200ae2e-ac4e-41b6-a1c3-0ea00703d7e32
1482515eslicarbazepine acetate 400 MG Oral TabletSCD6200ae2e-ac4e-41b6-a1c3-0ea00703d7e32
1482521eslicarbazepine acetate 600 MG Oral TabletSCD6200ae2e-ac4e-41b6-a1c3-0ea00703d7e32
1482525eslicarbazepine acetate 800 MG Oral TabletSCD6200ae2e-ac4e-41b6-a1c3-0ea00703d7e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-431-303172204313030 TABLET in 1 BOTTLE (31722-431-30) 30 tablet2023-08-03NoNoHistorical
31722-431-313172204313110 in 1 BLISTER PACKHistorical
31722-431-323172204313210 BLISTER PACK in 1 CARTON (31722-431-32) / 10 TABLET in 1 BLISTER PACK (31722-431-31) 10 blister pack2023-08-03NoNoHistorical
31722-431-903172204319090 TABLET in 1 BOTTLE (31722-431-90) 90 tablet2023-08-03NoNoHistorical