Oxcarbazepine

Product NDC: 70518-3237
Requested package NDC: 70518-3237-0
11-digit product format: 705183237
Labeler code: 70518
Product ID: 70518-3237_4b04e14b-81c3-42d7-e063-6394a90aaeaa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxcarbazepine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077802
Marketing category: ANDA
Marketing start: 2021-10-13
Substance: OXCARBAZEPINE
Active strength: 300 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3237	70518-3237-0	D	Discontinued by firm		2026-08-17

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-3237	70518-3237-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-3237	70518-3237-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-3237	70518-3237-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077802-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09
A077802-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09
A077802-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077802-001	AB
A077802-002	AB
A077802-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077802-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077802-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077802-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077802-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077802-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077802-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077802-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077802-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077802-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077802-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077802-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077802-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077802-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077802-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077802-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077802-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077802-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077802-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077802-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077802-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077802-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077802-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxcarbazepine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXCARBAZEPINE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VZI5B1W380	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312137	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a2032bcc-2da5-45e5-aa3f-ddbf50909df8	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-03-22	These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
2023-03-22	These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
2023-03-22	These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
2023-01-30	These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
2023-01-30	These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
2023-01-30	These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-3237-0	Oxcarbazepine	100 in 1 BOX	TABLET, FILM COATED	100	8
70518-3237-1	Oxcarbazepine	1 in 1 POUCH	TABLET, FILM COATED	1	8
70518-3237-2	Oxcarbazepine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3237	OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.]	5	Current NDC, Legacy NDC, 3 package rows	20250215_a2032bcc-2da5-45e5-aa3f-ddbf50909df8.zip

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	a2032bcc-2da5-45e5-aa3f-ddbf50909df8	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802 ndc (package): 70518-3237-0 ndc (product): 70518-3237 ndc11 (package): 70518323700
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	a90cd1f1-5258-4b0e-92fd-c4cebe47772b	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	51008af2-39ac-546c-e063-6294a90a758f	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	50873ef7-3deb-7386-e063-6394a90a9c19	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Glenmark Pharmaceuticals Inc., USA	1c713b59-a628-42e6-b166-ae71c3913284	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Direct_rx	21b0cc84-b64a-75de-e063-6294a90a9dd0	2024-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Proficient Rx LP	95867dcd-fd0e-4570-987b-d35939f7d7d1	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802

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
312137	OXcarbazepine 300 MG Oral Tablet	PSN	a2032bcc-2da5-45e5-aa3f-ddbf50909df8	8
312137	oxcarbazepine 300 MG Oral Tablet	SCD	a2032bcc-2da5-45e5-aa3f-ddbf50909df8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3237-0	70518323700	100 POUCH in 1 BOX (70518-3237-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3237-1)	100 pouch	2021-10-13	0000-00-00	No	No	Current