OXCARBAZEPINE

Product NDC: 60505-4130
11-digit product format: 605054130
Labeler code: 60505
Product ID: 60505-4130_f106ef3d-7def-b2e5-2428-60ecd16326f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXCARBAZEPINE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA213369
Marketing category: ANDA
Marketing start: 2024-09-03
Substance: OXCARBAZEPINE
Active strength: 600 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 43.

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
A213369-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13
A213369-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13
A213369-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213369-001	AB
A213369-002	AB
A213369-003	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 2 · 66 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
2026-09-14 22:38:34	2026-08	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213369-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213369-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213369-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213369-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213369-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213369-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213369-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213369-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213369-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213369-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213369-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213369-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213369-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213369-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213369-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213369-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213369-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213369-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213369-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213369-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213369-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213369-003	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213369-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213369-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213369-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXCARBAZEPINE	600 mg/1

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	Strength	SPL version
60505-4130-5	OXCARBAZEPINE	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500		6
60505-4130-7	OXCARBAZEPINE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-4130-7	EA - Each	60505-4130	54ef40c9-f34c-4f96-90c8-8b554ebebbe1	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-4130	OXCARBAZEPINE TABLET, EXTENDED RELEASE [APOTEX CORP.]	5	Current NDC, 2 package rows	20240913_a20e4a95-8ee1-e702-003e-e353ec1ee133.zip

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
1365653	OXcarbazepine 150 MG 24HR Extended Release Oral Tablet	PSN	a20e4a95-8ee1-e702-003e-e353ec1ee133	6
1365842	OXcarbazepine 300 MG 24HR Extended Release Oral Tablet	PSN	a20e4a95-8ee1-e702-003e-e353ec1ee133	6
1365844	OXcarbazepine 600 MG 24HR Extended Release Oral Tablet	PSN	a20e4a95-8ee1-e702-003e-e353ec1ee133	6
1365653	24 HR oxcarbazepine 150 MG Extended Release Oral Tablet	SCD	a20e4a95-8ee1-e702-003e-e353ec1ee133	6
1365842	24 HR oxcarbazepine 300 MG Extended Release Oral Tablet	SCD	a20e4a95-8ee1-e702-003e-e353ec1ee133	6
1365844	24 HR oxcarbazepine 600 MG Extended Release Oral Tablet	SCD	a20e4a95-8ee1-e702-003e-e353ec1ee133	6
1365653	oxcarbazepine 150 MG 24 HR Extended Release Oral Tablet	SY	a20e4a95-8ee1-e702-003e-e353ec1ee133	6
1365842	oxcarbazepine 300 MG 24 HR Extended Release Oral Tablet	SY	a20e4a95-8ee1-e702-003e-e353ec1ee133	6
1365844	oxcarbazepine 600 MG 24 HR Extended Release Oral Tablet	SY	a20e4a95-8ee1-e702-003e-e353ec1ee133	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
60505-4130-5	60505413005	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4130-5)	2024-09-03	No	No	Current
60505-4130-7	60505413007	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4130-7)	2024-09-03	No	No	Current