Eslicarbazepine Acetate

Product NDC: 60505-4661
Requested package NDC: 60505-4661-9
11-digit product format: 605054661
Labeler code: 60505
Product ID: 60505-4661_ce7f0fa9-9973-64fc-b9db-9f4edc82a224
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eslicarbazepine Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA211236
Marketing category: ANDA
Marketing start: 2025-05-06
Substance: ESLICARBAZEPINE ACETATE
Active strength: 800 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	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.

Application-product, TE code table
Application-product	TE code
A211236-001	AB
A211236-002	AB
A211236-003	AB
A211236-004	AB

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A211236-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211236-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211236-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A211236-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211236-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211236-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211236-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211236-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211236-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211236-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211236-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211236-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211236-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211236-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211236-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211236-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211236-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211236-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211236-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211236-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211236-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211236-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211236-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211236-004	AB	1	`6a471c1ec25d…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211236-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211236-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211236-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211236-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211236-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211236-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211236-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211236-004	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211236-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211236-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211236-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211236-004	AB	1	`a50c72e98297…`

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	800 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d24d1d2-3014-4f74-bf96-88297667a253	Product name	3	20240906

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-4661-3	Eslicarbazepine Acetate	30 in 1 BOTTLE	TABLET	30		2
60505-4661-9	Eslicarbazepine Acetate	90 in 1 BOTTLE	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-4661-3	EA - Each	60505-4661	97b05a61-ddcb-4d4a-ba01-037176190078	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-4661	ESLICARBAZEPINE ACETATE TABLET [APOTEX CORP.]	2	Current NDC, 2 package rows	20250507_22f29752-614f-caaf-b595-9deae8a3e3ff.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BEA68ZVB2K	ESLICARBAZEPINE ACETATE	236395-14-5	ESLICARBAZEPINE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1482507	eslicarbazepine acetate 200 MG Oral Tablet	PSN	22f29752-614f-caaf-b595-9deae8a3e3ff	2
1482515	eslicarbazepine acetate 400 MG Oral Tablet	PSN	22f29752-614f-caaf-b595-9deae8a3e3ff	2
1482521	eslicarbazepine acetate 600 MG Oral Tablet	PSN	22f29752-614f-caaf-b595-9deae8a3e3ff	2
1482525	eslicarbazepine acetate 800 MG Oral Tablet	PSN	22f29752-614f-caaf-b595-9deae8a3e3ff	2
1482507	eslicarbazepine acetate 200 MG Oral Tablet	SCD	22f29752-614f-caaf-b595-9deae8a3e3ff	2
1482515	eslicarbazepine acetate 400 MG Oral Tablet	SCD	22f29752-614f-caaf-b595-9deae8a3e3ff	2
1482521	eslicarbazepine acetate 600 MG Oral Tablet	SCD	22f29752-614f-caaf-b595-9deae8a3e3ff	2
1482525	eslicarbazepine acetate 800 MG Oral Tablet	SCD	22f29752-614f-caaf-b595-9deae8a3e3ff	2
1482507	eslicarbazepine acetate 200 MG Oral Tablet	PSN	3a3b3e50-6590-0040-e063-6294a90a84c1	1
1482515	eslicarbazepine acetate 400 MG Oral Tablet	PSN	3a3b3e50-6590-0040-e063-6294a90a84c1	1
1482521	eslicarbazepine acetate 600 MG Oral Tablet	PSN	3a3b3e50-6590-0040-e063-6294a90a84c1	1
1482525	eslicarbazepine acetate 800 MG Oral Tablet	PSN	3a3b3e50-6590-0040-e063-6294a90a84c1	1
1482507	eslicarbazepine acetate 200 MG Oral Tablet	SCD	3a3b3e50-6590-0040-e063-6294a90a84c1	1
1482515	eslicarbazepine acetate 400 MG Oral Tablet	SCD	3a3b3e50-6590-0040-e063-6294a90a84c1	1
1482521	eslicarbazepine acetate 600 MG Oral Tablet	SCD	3a3b3e50-6590-0040-e063-6294a90a84c1	1
1482525	eslicarbazepine acetate 800 MG Oral Tablet	SCD	3a3b3e50-6590-0040-e063-6294a90a84c1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60505-4661-9	60505466109	90 TABLET in 1 BOTTLE (60505-4661-9)	90 tablet	2025-05-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eslicarbazepine Acetate	Golden State Medical Supply, Inc.	2026-09-22	HUMAN PRESCRIPTION DRUG LABEL	2
Eslicarbazepine Acetate	Apotex Corp. \| Apotex Inc.	2026-09-11	HUMAN PRESCRIPTION DRUG LABEL	3