Home NDC 51407-780 Eslicarbazepine Acetate
Product NDC 51407-780
11-digit product format 514070780
Labeler code 51407
Product ID 51407-780_5c15b5e8-97c7-6030-e063-6294a90afc9e
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 400 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A211236-001 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-12-07 A211236-002 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-12-07 A211236-003 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-12-07 A211236-004 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-12-07
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 2026-10-15 13:18:30 2026-09 A211236-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-12-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211236-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-12-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211236-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-12-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211236-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-12-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211236-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-12-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211236-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-12-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211236-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-12-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211236-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-12-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211236-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211236-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211236-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211236-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211236-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211236-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211236-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211236-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211236-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211236-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211236-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211236-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211236-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2023-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211236-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2023-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211236-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2023-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211236-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2023-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211236-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2023-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211236-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2023-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211236-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2023-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211236-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2023-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211236-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2023-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211236-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2023-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211236-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2023-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211236-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2023-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211236-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2023-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211236-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2023-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211236-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2023-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211236-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2023-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211236-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2023-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211236-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2023-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211236-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2023-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211236-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2023-12-07 2680178bc6a6…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Eslicarbazepine Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESLICARBAZEPINE ACETATE 400 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51407-780-30 Eslicarbazepine Acetate 30 in 1 BOTTLE TABLET 30 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51407-780-30 51407078030 30 TABLET in 1 BOTTLE (51407-780-30) 30 tablet 2025-05-12 No No Current