OXCARBAZEPINE

Product NDC: 55700-868
11-digit product format: 557000868
Labeler code: 55700
Product ID: 55700-868_6a98498a-d448-43f7-a554-8ad8e4b3977c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXCARBAZEPINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA078069
Marketing category: ANDA
Marketing start: 2020-06-03
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55700-868		D	Discontinued by firm		2026-08-07
excluded package	package	55700-868	55700-868-60	D	Discontinued by firm		2026-08-07

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-868-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-868-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-868-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-868-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-868-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-868-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-868-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-868-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-868-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-868-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-868-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-868-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55700-868-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55700-868-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-868-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078069-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11
A078069-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11
A078069-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078069-001	AB
A078069-002	AB
A078069-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078069-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2008-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078069-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2008-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078069-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2008-01-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078069-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078069-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078069-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078069-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078069-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078069-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078069-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078069-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078069-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078069-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078069-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078069-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078069-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078069-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078069-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078069-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078069-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078069-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078069-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078069-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078069-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078069-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078069-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078069-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078069-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078069-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078069-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078069-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078069-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078069-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078069-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078069-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078069-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078069-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078069-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078069-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078069-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078069-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078069-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078069-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55700-868-60	2025-01-13	C162847	48780-1	f386c64a-28ca-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. Oxcarbazepine film-coated tablets, for oral use Initial U.S. Approval: 2000
55700-868-60	2023-01-30	C162847	48780-1	f386c64a-28ca-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. Oxcarbazepine film-coated tablets, for oral use Initial U.S. Approval: 2000

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-868-60	EA - Each	55700-868	35f8569a-b100-4dfd-a8bf-b0c6963ee8f4	1	2020-09-14

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	ffc8d10c-0049-4fe5-beb8-79cc6a197ede	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	85a9bdee-4d10-4097-ae3d-0bf8d844a11b	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Major Pharmaceuticals	b1d54def-057d-4608-bc8f-1d967ac3ec91	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	fcf5044a-8cfd-47d5-9f47-8f6674843c24	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Major Pharmaceuticals	567c0777-9bc5-45a9-ba25-959dd76d0e05	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Breckenridge Pharmaceutical, Inc.	54fb494e-bce4-442d-954a-757f9851e81e	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	244f9a68-5ab4-46b8-a01f-538572fd3c5f	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	6d2a6cac-f16b-4e6c-8f75-3afffb0a0f3b	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Golden State Medical Supply, Inc.	b9db5c45-8b51-449b-b4af-1a235c08f189	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	a1b6a698-f7d9-4adb-9e38-b63e7a85e2b3	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	1176d5f5-3447-4925-aed8-1a1cb4b5989d	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Coupler LLC	3f15c889-4386-850b-e063-6294a90a8dbf	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Preferred Pharmaceuticals Inc.	e156339c-f79e-4a20-b9da-f50bea948213	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Cardinal Health 107, LLC	4ebcb0e5-1c93-4b3f-8749-6835c56afce5	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	38694974-3dc6-42b5-bdf9-b5354e35330b	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	d8edaa2b-3bab-4030-a4e3-0c77f7655731	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	78f196d4-110e-45b1-813a-725f52c1a4eb	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	d3c7a3b8-b9a2-4a5f-98b3-0ed02eca3433	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069
OXCARBAZEPINE	OXCARBAZEPINE	Bryant Ranch Prepack	255f64ba-7667-48e6-8599-3b598bf6f4e9	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078069 application number: ANDA078069

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	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-868-60	55700086860	60 TABLET, FILM COATED in 1 BOTTLE (55700-868-60)	2020-06-03	0000-00-00	No	No	Current