OXCARBAZEPINE

Product NDC: 51672-1393
11-digit product format: 516721393
Labeler code: 51672
Product ID: 51672-1393_440646d8-f538-5968-e063-6394a90ab7cd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXCARBAZEPINE
Dosage form: SUSPENSION
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA078734
Marketing category: ANDA
Marketing start: 2025-08-06
Substance: OXCARBAZEPINE
Active strength: 60 mg/mL
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51672-1393		D	Discontinued by firm		2026-09-14
excluded package	package	51672-1393	51672-1393-1	D	Discontinued by firm		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078734-001	OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB		2009-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078734-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078734-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078734-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078734-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078734-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078734-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078734-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078734-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078734-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078734-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078734-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078734-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078734-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078734-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078734-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078734-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078734-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078734-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078734-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078734-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078734-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078734-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078734-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078734-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078734-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078734-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078734-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078734-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078734-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078734-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078734-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078734-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078734-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078734-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078734-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078734-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078734-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078734-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078734-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078734-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078734-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ca2a6da1-5711-44d0-9e79-c84d4265f98b	Product name	3	20250724
536d5b6b-66f1-478b-2670-88fd15947e3b	Product name	7	20250218
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51672-1393-1	OXCARBAZEPINE	1 in 1 CARTON	SUSPENSION	1		8
51672-1393-1	OXCARBAZEPINE	250 mL in 1 BOTTLE, GLASS	SUSPENSION	250		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-1393	OXCARBAZEPINE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	2	Current NDC, 2 package rows	20250125_9d5ba8a3-d1ea-4d5b-aafd-3a7ba2d4746c.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283536	oxacarbazepine 300 MG in 5 mL Oral Suspension	PSN	9d5ba8a3-d1ea-4d5b-aafd-3a7ba2d4746c	8
283536	oxcarbazepine 60 MG/ML Oral Suspension	SCD	9d5ba8a3-d1ea-4d5b-aafd-3a7ba2d4746c	8
283536	oxacarbazepine 300 MG per 5 ML Oral Suspension	SY	9d5ba8a3-d1ea-4d5b-aafd-3a7ba2d4746c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51672-1393-1	51672139301	1 BOTTLE, GLASS in 1 CARTON (51672-1393-1) / 250 mL in 1 BOTTLE, GLASS	2025-08-06	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXCARBAZEPINE	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-11-20	HUMAN PRESCRIPTION DRUG LABEL	8