OXCARBAZEPINE

Product NDC: 60505-4128
11-digit product format: 605054128
Labeler code: 60505
Product ID: 60505-4128_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: 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 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
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 · 60 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213369-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213369-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213369-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2023-07-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1365653	Internal RxNorm lookup
1365842	Internal RxNorm lookup
1365844	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
a20e4a95-8ee1-e702-003e-e353ec1ee133	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	Strength	SPL version
60505-4128-5	OXCARBAZEPINE	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500		6
60505-4128-7	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
60505-4128-7	EA - Each	60505-4128	089b4718-99de-4c5c-8718-f383d29c2b34	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-4128	OXCARBAZEPINE TABLET, EXTENDED RELEASE [APOTEX CORP.]	5	Current NDC, 2 package rows	20240913_a20e4a95-8ee1-e702-003e-e353ec1ee133.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXCARBAZEPINE	OXCARBAZEPINE	Apotex Corp.	a20e4a95-8ee1-e702-003e-e353ec1ee133	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213369 application number: ANDA213369 ndc (product): 60505-4128

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
60505-4128-5	60505412805	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4128-5)	2024-09-03	No	No	Current
60505-4128-7	60505412807	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4128-7)	2024-09-03	No	No	Current