Home NDC 68180-292 Eslicarbazepine Acetate
Product NDC 68180-292
11-digit product format 681800292
Labeler code 68180
Product ID 68180-292_e9e5b32f-72f3-4852-8bd6-0b539b8147c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eslicarbazepine Acetate
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA211246
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 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 A211246-001 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-03-27 A211246-002 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-03-27 A211246-003 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-03-27 A211246-004 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-03-27
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 · 72 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 A211246-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211246-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211246-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A211246-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-03-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A211246-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211246-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211246-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211246-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211246-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211246-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211246-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211246-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211246-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211246-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211246-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211246-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211246-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211246-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211246-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211246-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211246-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211246-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211246-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211246-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211246-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211246-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211246-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211246-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211246-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211246-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211246-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211246-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211246-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211246-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211246-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211246-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211246-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211246-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211246-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211246-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-03-27 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
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 600 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-292-07 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 68180-292 ESLICARBAZEPINE ACETATE TABLET [LUPIN PHARMACEUTICALS, INC.] 6 Current NDC, 1 package rows 20250508_999b341f-fe13-4dd9-bb95-9b0d6a817c4c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68180-292-07 68180029207 60 TABLET in 1 BOTTLE (68180-292-07) 60 tablet 2025-05-06 No No Current