Eslicarbazepine Acetate

Product NDC
51407-782
11-digit product format
514070782
Labeler code
51407
Product ID
51407-782_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
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211236-001ESLICARBAZEPINE ACETATEESLICARBAZEPINE ACETATE200MGTABLET / ORALAB2023-12-07
A211236-002ESLICARBAZEPINE ACETATEESLICARBAZEPINE ACETATE400MGTABLET / ORALAB2023-12-07
A211236-003ESLICARBAZEPINE ACETATEESLICARBAZEPINE ACETATE600MGTABLET / ORALAB2023-12-07
A211236-004ESLICARBAZEPINE ACETATEESLICARBAZEPINE ACETATE800MGTABLET / ORALAB2023-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A211236-001AB
A211236-002AB
A211236-003AB
A211236-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211236-001ESLICARBAZEPINE ACETATE200MGTABLET / ORALAB2023-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211236-002ESLICARBAZEPINE ACETATE400MGTABLET / ORALAB2023-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211236-003ESLICARBAZEPINE ACETATE600MGTABLET / ORALAB2023-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211236-004ESLICARBAZEPINE ACETATE800MGTABLET / ORALAB2023-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211236-001ESLICARBAZEPINE ACETATE200MGTABLET / ORALAB2023-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211236-002ESLICARBAZEPINE ACETATE400MGTABLET / ORALAB2023-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211236-003ESLICARBAZEPINE ACETATE600MGTABLET / ORALAB2023-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211236-004ESLICARBAZEPINE ACETATE800MGTABLET / ORALAB2023-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A211236-001ESLICARBAZEPINE ACETATE200MGTABLET / ORALAB2023-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211236-002ESLICARBAZEPINE ACETATE400MGTABLET / ORALAB2023-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211236-003ESLICARBAZEPINE ACETATE600MGTABLET / ORALAB2023-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211236-004ESLICARBAZEPINE ACETATE800MGTABLET / ORALAB2023-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211236-001ESLICARBAZEPINE ACETATE200MGTABLET / ORAL2023-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211236-002ESLICARBAZEPINE ACETATE400MGTABLET / ORAL2023-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211236-003ESLICARBAZEPINE ACETATE600MGTABLET / ORAL2023-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211236-004ESLICARBAZEPINE ACETATE800MGTABLET / ORAL2023-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211236-001ESLICARBAZEPINE ACETATE200MGTABLET / ORAL2023-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211236-002ESLICARBAZEPINE ACETATE400MGTABLET / ORAL2023-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211236-003ESLICARBAZEPINE ACETATE600MGTABLET / ORAL2023-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211236-004ESLICARBAZEPINE ACETATE800MGTABLET / ORAL2023-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211236-001ESLICARBAZEPINE ACETATE200MGTABLET / ORAL2023-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211236-002ESLICARBAZEPINE ACETATE400MGTABLET / ORAL2023-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211236-003ESLICARBAZEPINE ACETATE600MGTABLET / ORAL2023-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211236-004ESLICARBAZEPINE ACETATE800MGTABLET / ORAL2023-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211236-001ESLICARBAZEPINE ACETATE200MGTABLET / ORAL2023-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211236-002ESLICARBAZEPINE ACETATE400MGTABLET / ORAL2023-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211236-003ESLICARBAZEPINE ACETATE600MGTABLET / ORAL2023-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211236-004ESLICARBAZEPINE ACETATE800MGTABLET / ORAL2023-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211236-001ESLICARBAZEPINE ACETATE200MGTABLET / ORAL2023-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211236-002ESLICARBAZEPINE ACETATE400MGTABLET / ORAL2023-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211236-003ESLICARBAZEPINE ACETATE600MGTABLET / ORAL2023-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211236-004ESLICARBAZEPINE ACETATE800MGTABLET / ORAL2023-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211236-001ESLICARBAZEPINE ACETATE200MGTABLET / ORAL2023-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211236-002ESLICARBAZEPINE ACETATE400MGTABLET / ORAL2023-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211236-003ESLICARBAZEPINE ACETATE600MGTABLET / ORAL2023-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211236-004ESLICARBAZEPINE ACETATE800MGTABLET / ORAL2023-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211236-001ESLICARBAZEPINE ACETATE200MGTABLET / ORAL2023-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A211236-002ESLICARBAZEPINE ACETATE400MGTABLET / ORAL2023-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A211236-003ESLICARBAZEPINE ACETATE600MGTABLET / ORAL2023-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A211236-004ESLICARBAZEPINE ACETATE800MGTABLET / ORAL2023-12-07d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211236-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211236-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211236-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211236-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211236-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211236-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211236-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211236-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211236-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211236-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211236-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211236-004AB16a471c1ec25d…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211236-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211236-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211236-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211236-004AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211236-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A211236-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A211236-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A211236-004AB11c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211236-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211236-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211236-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211236-004AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BEA68ZVB2KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1482507Internal RxNorm lookup
1482515Internal RxNorm lookup
1482521Internal RxNorm lookup
1482525Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a3b3e50-6590-0040-e063-6294a90a84c1Available on FDA.report

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
51407-782-30Eslicarbazepine Acetate30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-782-30EA - Each51407-78239b79b8c-1358-476f-a969-f4313d8fc94c12025-08-11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eslicarbazepine AcetateESLICARBAZEPINE ACETATEGolden State Medical Supply, Inc.3a3b3e50-6590-0040-e063-6294a90a84c12025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211236
application number: ANDA211236
ndc (product): 51407-782
Eslicarbazepine AcetateESLICARBAZEPINE ACETATEApotex Corp.22f29752-614f-caaf-b595-9deae8a3e3ff2025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211236
application number: ANDA211236

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
51407-782-305140707823030 TABLET in 1 BOTTLE (51407-782-30) 30 tablet2025-05-12NoNoCurrent