Oxcarbazepine

Product NDC: 70518-3921
11-digit product format: 705183921
Labeler code: 70518
Product ID: 70518-3921_3646eab6-6f97-cf2b-e063-6294a90a1b93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxcarbazepine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA215939
Marketing category: ANDA
Marketing start: 2023-11-22
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: 2026-12-31
Current FDA listing: Yes

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
A215939-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11
A215939-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11
A215939-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215939-001	AB
A215939-002	AB
A215939-003	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 3 · 96 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	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215939-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2022-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215939-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2022-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215939-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2022-01-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 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	A215939-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215939-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215939-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215939-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215939-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215939-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215939-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215939-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215939-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215939-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215939-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215939-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215939-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215939-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215939-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215939-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215939-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215939-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215939-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215939-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215939-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215939-001	AB	1	`8072bd15b7f6…`

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
0abe9478-4084-286d-e063-6294a90a9ba7	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-3921-0	Oxcarbazepine	100 in 1 BOX	TABLET, FILM COATED	100		4
70518-3921-1	Oxcarbazepine	1 in 1 POUCH	TABLET, FILM COATED	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3921	OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.]	3	Current NDC, 2 package rows	20240723_0abe9478-4084-286d-e063-6294a90a9ba7.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	Cardinal Health 107, LLC	3e0f8d9f-7659-4524-8f93-6200314356c8	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	American Health Packaging	c0f9df3f-280e-4394-8d7e-ad04803b2635	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	c7718f8b-63e2-40b9-b519-e687cfc2cacf	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	188a48ad-c412-416a-b15b-de5f232740a2	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	0abe9478-4084-286d-e063-6294a90a9ba7	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939 ndc (product): 70518-3921
Oxcarbazepine	OXCARBAZEPINE	ASCLEMED USA INC.	c42b2cb2-8b45-488b-bf63-81909a1f06cb	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	512ab25c-ea79-1e59-e063-6294a90ae9a0	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	NCS HealthCare of KY, LLC dba Vangard Labs	3fb47782-3dfc-458c-92a6-493de1207c0e	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
OXCARBAZEPINE	OXCARBAZEPINE	NorthStar RxLLC	20d826cd-fa4a-4570-9e10-9d7d10fb725b	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	Camber Pharmaceuticals, Inc.	fe49a773-562c-4da6-96b7-bba52f4d61e2	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	Proficient Rx LP	433d9d03-a36e-42c6-8e4d-f333ed60e45a	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	Bryant Ranch Prepack	23137a89-cbd0-4a5f-8220-f26b7ba54330	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	AvPAK	fd8da0e9-d69b-7587-e053-6294a90a33c0	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939
Oxcarbazepine	OXCARBAZEPINE	XLCare Pharmaceuticals Inc.	9f5d17e4-ca68-48e2-9e87-d3ab1c59aa93	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215939 application number: ANDA215939

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	0abe9478-4084-286d-e063-6294a90a9ba7	4
312137	oxcarbazepine 300 MG Oral Tablet	SCD	0abe9478-4084-286d-e063-6294a90a9ba7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3921-0	70518392100	100 POUCH in 1 BOX (70518-3921-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3921-1)	100 pouch	2023-11-22	No	No	Current
70518-3921-1	70518392101	1 in 1 POUCH					Historical