OXCARBAZEPINE

Product NDC: 63629-3816
11-digit product format: 636293816
Labeler code: 63629
Product ID: 63629-3816_e1e371c0-49d4-401e-8e7c-b953f579480e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXCARBAZEPINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078069
Marketing category: ANDA
Marketing start: 2008-01-11
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: 2026-12-31
Current FDA listing: Yes

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 · 4 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	63629-3816-2
excluded package	package	63629-3816-1
excluded package	package	63629-3816-3

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: OXCARBAZEPINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXCARBAZEPINE	150 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
312136	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
78f196d4-110e-45b1-813a-725f52c1a4eb	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#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-3816-1	2020-10-16	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
63629-3816-2	2020-10-16	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
63629-3816-3	2020-10-16	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
63629-3816-1	2020-01-31	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
63629-3816-2	2020-01-31	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
63629-3816-3	2020-01-31	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-3816-1	OXCARBAZEPINE	30 in 1 BOTTLE	TABLET, FILM COATED	30	1007
63629-3816-2	OXCARBAZEPINE	60 in 1 BOTTLE	TABLET, FILM COATED	60	1007
63629-3816-3	OXCARBAZEPINE	90 in 1 BOTTLE	TABLET, FILM COATED	90	1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3816-1	EA - Each	63629-3816	6e0582bb-a1f4-400c-99f1-7279cd20f145	1	2013-02-13
63629-3816-2	EA - Each	63629-3816	ead77141-e4bf-41b6-9ef3-9a0d73512f60	1	2013-02-13
63629-3816-3	EA - Each	63629-3816	cb88bdb8-1b3e-4b47-b45c-db5a8635f778	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXCARBAZEPINE	ACTIVE INGREDIENT	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-3816	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1007	Current NDC, Legacy NDC, 3 package rows	20240511_78f196d4-110e-45b1-813a-725f52c1a4eb.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 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 ndc (product): 63629-3816
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312136	OXcarbazepine 150 MG Oral Tablet	PSN	78f196d4-110e-45b1-813a-725f52c1a4eb	1007
312136	oxcarbazepine 150 MG Oral Tablet	SCD	78f196d4-110e-45b1-813a-725f52c1a4eb	1007

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3816-1	63629381601	30 TABLET, FILM COATED in 1 BOTTLE (63629-3816-1)	2011-07-28	0000-00-00	No	No	Current
63629-3816-2	63629381602	60 TABLET, FILM COATED in 1 BOTTLE (63629-3816-2)	2008-10-14	0000-00-00	No	No	Current
63629-3816-3	63629381603	90 TABLET, FILM COATED in 1 BOTTLE (63629-3816-3)	2012-08-06	0000-00-00	No	No	Current