OXTELLAR XR

Product NDC: 17772-123
11-digit product format: 177720123
Labeler code: 17772
Product ID: 17772-123_41c1a4d4-ff5a-00b4-e063-6294a90a6ec7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXCARBAZEPINE
Dosage form: TABLET
Route: ORAL
Labeler: Supernus Pharmaceuticals, Inc.
Application: NDA202810
Marketing category: NDA
Marketing start: 2013-01-17
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	RLD / RS	Approval date
N202810-001	OXTELLAR XR	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19
N202810-002	OXTELLAR XR	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19
N202810-003	OXTELLAR XR	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N202810-001	AB
N202810-002	AB
N202810-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202810-001	10220042	2027-04-13	U-2501		2019-03-28
N202810-001	11166960	2027-04-13		Drug product	2021-11-24
N202810-001	11896599	2027-04-13		Drug product	2024-02-28
N202810-001	7722898	2027-04-13		Drug product	2012-11-20
N202810-001	7910131	2027-04-13	U-2041		2012-11-20
N202810-001	8617600	2027-04-13		Drug product
N202810-001	8821930	2027-04-13		Drug product
N202810-001	9119791	2027-04-13	U-2041		2015-09-11
N202810-001	9351975	2027-04-13		Drug product	2016-06-10
N202810-001	9370525	2027-04-13		Drug product	2016-06-24
N202810-001	9855278	2027-04-13		Drug product	2018-01-05
N202810-002	10220042	2027-04-13	U-2501		2019-03-28
N202810-002	11166960	2027-04-13		Drug product	2021-11-24
N202810-002	11896599	2027-04-13		Drug product	2024-02-28
N202810-002	7722898	2027-04-13		Drug product
N202810-002	7910131	2027-04-13	U-2041
N202810-002	8617600	2027-04-13		Drug product
N202810-002	8821930	2027-04-13		Drug product
N202810-002	9119791	2027-04-13	U-2041		2015-09-11
N202810-002	9351975	2027-04-13		Drug product	2016-06-10
N202810-002	9370525	2027-04-13		Drug product	2016-06-24
N202810-002	9855278	2027-04-13		Drug product	2018-01-05
N202810-003	10220042	2027-04-13	U-2501		2019-03-28
N202810-003	11166960	2027-04-13		Drug product	2021-11-24
N202810-003	11896599	2027-04-13		Drug product	2024-02-28
N202810-003	7722898	2027-04-13		Drug product
N202810-003	7910131	2027-04-13	U-2041
N202810-003	8617600	2027-04-13		Drug product
N202810-003	8821930	2027-04-13		Drug product
N202810-003	9119791	2027-04-13	U-2041		2015-09-11
N202810-003	9351975	2027-04-13		Drug product	2016-06-10
N202810-003	9370525	2027-04-13		Drug product	2016-06-24
N202810-003	9855278	2027-04-13		Drug product	2018-01-05

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N202810-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202810-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202810-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202810-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202810-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202810-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202810-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202810-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202810-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-001	AB	1	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 33 · 1,320 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202810-001	10220042	2027-04-13	U-2501		2019-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	11166960	2027-04-13		Drug product	2021-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	11896599	2027-04-13		Drug product	2024-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	7722898	2027-04-13		Drug product	2012-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	7910131	2027-04-13	U-2041		2012-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	8617600	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	8821930	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	9119791	2027-04-13	U-2041		2015-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	9351975	2027-04-13		Drug product	2016-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	9370525	2027-04-13		Drug product	2016-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	9855278	2027-04-13		Drug product	2018-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	10220042	2027-04-13	U-2501		2019-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	11166960	2027-04-13		Drug product	2021-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	11896599	2027-04-13		Drug product	2024-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	7722898	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	7910131	2027-04-13	U-2041			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	8617600	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	8821930	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	9119791	2027-04-13	U-2041		2015-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	9351975	2027-04-13		Drug product	2016-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	9370525	2027-04-13		Drug product	2016-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	9855278	2027-04-13		Drug product	2018-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	10220042	2027-04-13	U-2501		2019-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	11166960	2027-04-13		Drug product	2021-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	11896599	2027-04-13		Drug product	2024-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	7722898	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	7910131	2027-04-13	U-2041			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	8617600	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	8821930	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	9119791	2027-04-13	U-2041		2015-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	9351975	2027-04-13		Drug product	2016-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	9370525	2027-04-13		Drug product	2016-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	9855278	2027-04-13		Drug product	2018-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202810-001	10220042	2027-04-13	U-2501		2019-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	11166960	2027-04-13		Drug product	2021-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	11896599	2027-04-13		Drug product	2024-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	7722898	2027-04-13		Drug product	2012-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	7910131	2027-04-13	U-2041		2012-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	8617600	2027-04-13		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	8821930	2027-04-13		Drug product		`caaa826d4ba7…`

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: OXTELLAR XR
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
17772-123-01	2025-08-15	OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-01	2025-08-15	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-01	2025-08-15	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-07	2025-08-15	OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-07	2025-08-15	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-07	2025-08-15	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-10	2025-08-15	OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-10	2025-08-15	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-10	2025-08-15	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-01	2025-07-29	OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-01	2025-07-29	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-01	2025-07-29	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-07	2025-07-29	OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-07	2025-07-29	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-07	2025-07-29	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-10	2025-07-29	OXTELLAR XR® - These highlights do not include all the information needed to use OXTELLAR XR® safely and effectively. See full prescribing information for OXTELLAR XR®. OXTELLAR XR® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-10	2025-07-29	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release tablets, for oral use Initial U.S. Approval: 2000
17772-123-10	2025-07-29	These highlights do not include all the information needed to use OXTELLAR XR ® safely and effectively. See full prescribing information for OXTELLAR XR ® . OXTELLAR XR ® (oxcarbazepine) extended-release 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
17772-123-01	OXTELLAR XR	100 in 1 BOTTLE	TABLET	100	21
17772-123-07	OXTELLAR XR	7 in 1 BOTTLE	TABLET	7	21
17772-123-10	OXTELLAR XR	5 in 1 BLISTER PACK	TABLET	5	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17772-123-01	EA - Each	17772-123	c1832203-ef61-41af-b52f-6265c313176f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXCARBAZEPINE	ACTIVE INGREDIENT	VZI5B1W380	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
POLYETHYLENE GLYCOL 2000	INACTIVE INGREDIENT	HAF0412YIT	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17772-123	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS PHARMACEUTICALS, INC.]	18	Current NDC, Legacy NDC, 3 package rows	20241013_aa610e56-1d1d-11e1-8bc2-0800200c9a66.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	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365842	OXcarbazepine 300 MG 24HR Extended Release Oral Tablet	PSN	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365844	OXcarbazepine 600 MG 24HR Extended Release Oral Tablet	PSN	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365660	Oxtellar XR 150 MG 24HR Extended Release Oral Tablet, Once-Daily	PSN	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365847	Oxtellar XR 300 MG 24HR Extended Release Oral Tablet, Once-Daily	PSN	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365850	Oxtellar XR 600 MG 24HR Extended Release Oral Tablet, Once-Daily	PSN	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365660	24 HR oxcarbazepine 150 MG Extended Release Oral Tablet [Oxtellar]	SBD	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365847	24 HR oxcarbazepine 300 MG Extended Release Oral Tablet [Oxtellar]	SBD	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365850	24 HR oxcarbazepine 600 MG Extended Release Oral Tablet [Oxtellar]	SBD	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365653	24 HR oxcarbazepine 150 MG Extended Release Oral Tablet	SCD	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365842	24 HR oxcarbazepine 300 MG Extended Release Oral Tablet	SCD	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365844	24 HR oxcarbazepine 600 MG Extended Release Oral Tablet	SCD	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365660	24 HR Oxtellar 150 MG Extended Release Oral Tablet	SY	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365847	24 HR Oxtellar 300 MG Extended Release Oral Tablet	SY	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365850	24 HR Oxtellar 600 MG Extended Release Oral Tablet	SY	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365653	oxcarbazepine 150 MG 24 HR Extended Release Oral Tablet	SY	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365842	oxcarbazepine 300 MG 24 HR Extended Release Oral Tablet	SY	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365844	oxcarbazepine 600 MG 24 HR Extended Release Oral Tablet	SY	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365660	Oxtellar XR 150 MG 24 HR Extended Release Oral Tablet	SY	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365847	Oxtellar XR 300 MG 24 HR Extended Release Oral Tablet	SY	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21
1365850	Oxtellar XR 600 MG 24 HR Extended Release Oral Tablet	SY	aa610e56-1d1d-11e1-8bc2-0800200c9a66	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17772-123-01	17772012301	100 TABLET in 1 BOTTLE (17772-123-01)	100 tablet	2013-01-17	0000-00-00	No	No	Current
17772-123-07	17772012307	7 TABLET in 1 BOTTLE (17772-123-07)	7 tablet	2023-07-01		Yes	No	Current
17772-123-10	17772012310	5 TABLET in 1 BLISTER PACK (17772-123-10)	5 tablet	2013-01-17	0000-00-00	Yes	No	Current