Oxcarbazepine

Product NDC: 51672-4105
11-digit product format: 516724105
Labeler code: 51672
Product ID: 51672-4105_802f2425-e2a0-483a-8378-6c579e7738a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxcarbazepine
Dosage form: TABLET
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA077801
Marketing category: ANDA
Marketing start: 2007-11-15
Marketing end: 0000-00-00
Substance: OXCARBAZEPINE
Active strength: 150 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51672-4105		D	Discontinued by firm	2026-10-15
excluded package	package	51672-4105	51672-4105-0	D	Discontinued by firm	2026-10-15
excluded package	package	51672-4105	51672-4105-1	D	Discontinued by firm	2026-10-15
excluded package	package	51672-4105	51672-4105-3	D	Discontinued by firm	2026-10-15
excluded package	package	51672-4105	51672-4105-6	D	Discontinued by firm	2026-10-15

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 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	51672-4105-1
excluded package	package	51672-4105-3
excluded package	package	51672-4105-6
excluded package	package	51672-4105-0

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077801-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15
A077801-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15
A077801-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077801-001	AB
A077801-002	AB
A077801-003	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 4 · 132 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	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077801-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077801-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077801-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-11-15	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077801-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077801-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077801-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077801-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077801-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077801-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077801-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077801-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077801-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077801-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077801-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077801-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077801-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077801-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077801-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077801-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077801-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077801-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077801-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077801-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077801-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077801-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077801-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077801-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077801-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077801-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077801-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077801-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077801-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077801-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077801-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077801-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077801-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077801-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077801-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077801-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077801-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077801-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077801-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077801-002	AB	1	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4105-1	EA - Each	51672-4105	f1068a61-138a-4690-a23c-c191bc529b6a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Oxcarbazepine	ACTIVE INGREDIENT	VZI5B1W380	OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
Oxcarbazepine	ACTIVE MOIETY	VZI5B1W380	OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4105	OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]	8	Legacy NDC	20241212_17325a80-fb9c-4a83-b4b4-98e0b999d852.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VZI5B1W380	OXCARBAZEPINE	28721-07-5	OXCARBAZEPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4105-0	51672410500	10 BLISTER PACK in 1 CARTON (51672-4105-0) > 10 TABLET in 1 BLISTER PACK	10 blister pack	2007-11-15	0000-00-00	No	No	Current
51672-4105-1	51672410501	100 TABLET in 1 BOTTLE (51672-4105-1)	100 tablet	2007-11-15	0000-00-00	No	No	Current
51672-4105-3	51672410503	1000 TABLET in 1 BOTTLE (51672-4105-3)	1000 tablet	2007-11-15	0000-00-00	No	No	Current
51672-4105-6	51672410506	30 TABLET in 1 BOTTLE (51672-4105-6)	30 tablet	2007-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxcarbazepine	Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries, Ltd.	2024-12-10	HUMAN PRESCRIPTION DRUG LABEL	8