Home NDC 59651-534 ESLICARBAZEPINE ACETATE
Product NDC 59651-534
11-digit product format 596510534
Labeler code 59651
Product ID 59651-534_2067fb77-9657-44da-b430-02e8a4efacb5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESLICARBAZEPINE ACETATE
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA216481
Marketing category ANDA
Marketing start 2026-08-05
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 43 .
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 A216481-001 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2026-08-05 A216481-002 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2026-08-05 A216481-003 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2026-08-05 A216481-004 ESLICARBAZEPINE ACETATE ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2026-08-05
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.
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 2026-09-14 22:38:34 2026-08 A216481-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2026-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216481-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2026-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216481-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2026-08-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216481-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2026-08-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216481-001 ESLICARBAZEPINE ACETATE 200MG TABLET / ORAL AB 2026-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216481-002 ESLICARBAZEPINE ACETATE 400MG TABLET / ORAL AB 2026-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216481-003 ESLICARBAZEPINE ACETATE 600MG TABLET / ORAL AB 2026-08-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216481-004 ESLICARBAZEPINE ACETATE 800MG TABLET / ORAL AB 2026-08-05 caaa826d4ba7…
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
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-534-30 59651053430 30 TABLET in 1 BOTTLE (59651-534-30) 30 tablet 2026-08-05 No No Current