Oxcarbazepine

Product NDC: 71205-411
11-digit product format: 712050411
Labeler code: 71205
Product ID: 71205-411_0f92415d-6d81-4cc1-9a3b-028430951eb8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxcarbazepine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077802
Marketing category: ANDA
Marketing start: 2007-10-09
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

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: 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
95867dcd-fd0e-4570-987b-d35939f7d7d1	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-411-30	Oxcarbazepine	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
71205-411-60	Oxcarbazepine	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
71205-411-90	Oxcarbazepine	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-411-60	EA - Each	71205-411	bf9069b0-fce0-48b7-91cb-c2c4cd634f00	1	2020-04-20
71205-411-90	EA - Each	71205-411	9d328406-a282-47ec-b028-c1b230a4f0df	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-411	OXCARBAZEPINE TABLET, FILM COATED [PROFICIENT RX LP]	2	Current NDC, Legacy NDC, 3 package rows	20221111_95867dcd-fd0e-4570-987b-d35939f7d7d1.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
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 ndc (product): 71205-411

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	95867dcd-fd0e-4570-987b-d35939f7d7d1	2
312136	oxcarbazepine 150 MG Oral Tablet	SCD	95867dcd-fd0e-4570-987b-d35939f7d7d1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-411-30	71205041130	30 TABLET, FILM COATED in 1 BOTTLE (71205-411-30)	2020-02-26	0000-00-00	No	No	Current
71205-411-60	71205041160	60 TABLET, FILM COATED in 1 BOTTLE (71205-411-60)	2020-02-26	0000-00-00	No	No	Current
71205-411-90	71205041190	90 TABLET, FILM COATED in 1 BOTTLE (71205-411-90)	2020-02-26	0000-00-00	No	No	Current