Home NDC 67877-587 Eslicarbazepine Acetate
Product NDC 67877-587
11-digit product format 678770587
Labeler code 67877
Product ID 67877-587_ca4bcb9f-157d-4d49-92f5-6b76745aabe1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eslicarbazepine Acetate
Dosage form TABLET
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA211199
Marketing category ANDA
Marketing start 2025-05-06
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211199-001 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 A211199-002 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 A211199-003 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 A211199-004 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 80 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211199-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211199-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211199-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211199-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-10-06 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-001 PC 2025-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-002 PC 2025-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-003 PC 2025-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211199-004 PC 2025-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211199-001 PC 2025-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-002 PC 2025-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-003 PC 2025-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211199-004 PC 2025-11-02 6a471c1ec25d…
Additional Listing Data#
Finished product Yes
Brand name base Eslicarbazepine Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESLICARBAZEPINE ACETATE 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BEA68ZVB2K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1482507 Internal RxNorm lookup 1482515 Internal RxNorm lookup 1482521 Internal RxNorm lookup 1482525 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67877-587-60 Eslicarbazepine Acetate 60 in 1 BOTTLE TABLET 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-587 ESLICARBAZEPINE ACETATE TABLET [ASCEND LABORATORIES, LLC] 6 Current NDC, 1 package rows 20250507_28efe9d2-9d7b-4a7c-8458-098456d06604.zip
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67877-587-60 67877058760 60 TABLET in 1 BOTTLE (67877-587-60) 60 tablet 2025-05-06 No No Current