OXTELLAR XR

Product NDC: 17772-122
11-digit product format: 177720122
Labeler code: 17772
Product ID: 17772-122_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: 300 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	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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202810-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202810-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202810-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202810-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 32 · 1,254 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202810-001	10220042	2027-04-13	U-2501		2019-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	11166960	2027-04-13		Drug product	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	11896599	2027-04-13		Drug product	2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	7722898	2027-04-13		Drug product	2012-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	7910131	2027-04-13	U-2041		2012-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	8617600	2027-04-13		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	8821930	2027-04-13		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	9119791	2027-04-13	U-2041		2015-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	9351975	2027-04-13		Drug product	2016-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	9370525	2027-04-13		Drug product	2016-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	9855278	2027-04-13		Drug product	2018-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	10220042	2027-04-13	U-2501		2019-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	11166960	2027-04-13		Drug product	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	11896599	2027-04-13		Drug product	2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	7722898	2027-04-13		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	7910131	2027-04-13	U-2041			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	8617600	2027-04-13		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	8821930	2027-04-13		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	9119791	2027-04-13	U-2041		2015-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	9351975	2027-04-13		Drug product	2016-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	9370525	2027-04-13		Drug product	2016-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	9855278	2027-04-13		Drug product	2018-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	10220042	2027-04-13	U-2501		2019-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	11166960	2027-04-13		Drug product	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	11896599	2027-04-13		Drug product	2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	7722898	2027-04-13		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	7910131	2027-04-13	U-2041			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	8617600	2027-04-13		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	8821930	2027-04-13		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	9119791	2027-04-13	U-2041		2015-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	9351975	2027-04-13		Drug product	2016-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	9370525	2027-04-13		Drug product	2016-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	9855278	2027-04-13		Drug product	2018-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	10220042	2027-04-13	U-2501		2019-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	11166960	2027-04-13		Drug product	2021-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	11896599	2027-04-13		Drug product	2024-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	7722898	2027-04-13		Drug product	2012-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	7910131	2027-04-13	U-2041		2012-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	8617600	2027-04-13		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	8821930	2027-04-13		Drug product		`31067a03dcf5…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXCARBAZEPINE	300 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1365653	Internal RxNorm lookup
1365660	Internal RxNorm lookup
1365842	Internal RxNorm lookup
1365844	Internal RxNorm lookup
1365847	Internal RxNorm lookup
1365850	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
aa610e56-1d1d-11e1-8bc2-0800200c9a66	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
17772-122-01	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
17772-122-01	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
17772-122-07	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
17772-122-07	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
17772-122-10	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
17772-122-10	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
17772-122-01	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
17772-122-01	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
17772-122-07	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
17772-122-07	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
17772-122-10	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
17772-122-10	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
17772-122-01	OXTELLAR XR	100 in 1 BOTTLE	TABLET	100	21
17772-122-07	OXTELLAR XR	7 in 1 BOTTLE	TABLET	7	21
17772-122-10	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
17772-122-01	EA - Each	17772-122	208a0a4d-ebdd-4341-827d-f83769c85ab8	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
17772-122	OXTELLAR XR (OXCARBAZEPINE) TABLET [SUPERNUS PHARMACEUTICALS, INC.]	18	Current NDC, Legacy NDC, 3 package rows	20241013_aa610e56-1d1d-11e1-8bc2-0800200c9a66.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
OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	aa610e56-1d1d-11e1-8bc2-0800200c9a66	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202810 application number: NDA202810 ndc (product): 17772-122

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
17772-122-01	17772012201	100 TABLET in 1 BOTTLE (17772-122-01)	100 tablet	2013-01-17	0000-00-00	No	No	Current
17772-122-07	17772012207	7 TABLET in 1 BOTTLE (17772-122-07)	7 tablet	2023-07-01		Yes	No	Current
17772-122-10	17772012210	5 TABLET in 1 BLISTER PACK (17772-122-10)	5 tablet	2013-01-17	0000-00-00	Yes	No	Current