Home NDC 13668-538-30 Eslicarbazepine acetate
Product NDC 13668-538
Requested package NDC 13668-538-30
11-digit product format 136680538
Labeler code 13668
Product ID 13668-538_3b2943e4-21ea-828b-e063-6294a90a275b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eslicarbazepine acetate
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA211227
Marketing category ANDA
Marketing start 2025-05-06
Substance ESLICARBAZEPINE ACETATE
Active strength 200 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A211227-001 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-02-27 A211227-002 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-02-27 A211227-003 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-02-27 A211227-004 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-02-27
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 · 64 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 A211227-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211227-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211227-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211227-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211227-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211227-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211227-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211227-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211227-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2024-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211227-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2024-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211227-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2024-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211227-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2024-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211227-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211227-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211227-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211227-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211227-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211227-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211227-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211227-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211227-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211227-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211227-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211227-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211227-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211227-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211227-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211227-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211227-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211227-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211227-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211227-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211227-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211227-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211227-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211227-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211227-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL 2024-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211227-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL 2024-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211227-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL 2024-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211227-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL 2024-02-27 d06236e962d9…
Observed Orange Book normalized TE history# 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 200 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 13668-538-05 Eslicarbazepine acetate 500 in 1 BOTTLE TABLET 500 6 13668-538-30 Eslicarbazepine acetate 30 in 1 BOTTLE TABLET 30 6 13668-538-60 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 13668-538 ESLICARBAZEPINE ACETATE TABLET [TORRENT PHARMACEUTICALS LIMITED] 5 Current NDC, 3 package rows 20250507_d279e461-2611-4f5c-938d-5d117612894f.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 13668-538-30 13668053830 30 TABLET in 1 BOTTLE (13668-538-30) 30 tablet 2025-05-06 No No Current