Trokendi XR

Product NDC: 17772-102
11-digit product format: 177720102
Labeler code: 17772
Product ID: 17772-102_5b8a1778-ed48-a5a4-e063-6394a90a581c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Supernus Pharmaceuticals, Inc.
Application: NDA201635
Marketing category: NDA
Marketing start: 2013-08-16
Substance: TOPIRAMATE
Active strength: 50 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17772-102	17772-102-15	D	Discontinued by firm		2026-10-05
excluded package	package	17772-102	17772-102-70	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	17772-102-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	17772-102-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	17772-102-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	17772-102-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	17772-102-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	17772-102-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	17772-102-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	17772-102-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	17772-102-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	17772-102-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	17772-102-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	17772-102-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	17772-102-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	17772-102-70	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	17772-102-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	17772-102-70	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	17772-102-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	17772-102-70	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	17772-102-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	17772-102-70	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	17772-102-70	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	17772-102-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	17772-102-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	17772-102-70	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N201635-001	TROKENDI XR	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16
N201635-002	TROKENDI XR	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16
N201635-003	TROKENDI XR	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16
N201635-004	TROKENDI XR	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N201635-001	AB1
N201635-002	AB1
N201635-003	AB1
N201635-004	AB1

Orange Book patents#

Current patent rows page 1 of 1 · 80 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201635-001	10314790	2027-11-16	U-1675	Drug product	2019-07-09
N201635-001	10314790	2027-11-16	U-1992	Drug product	2019-07-09
N201635-001	8298580	2027-11-16	U-106	Drug product	2013-08-22
N201635-001	8298580	2027-11-16	U-1992	Drug product	2013-08-22
N201635-001	8663683	2027-11-16	U-106	Drug product
N201635-001	8663683	2027-11-16	U-1992	Drug product
N201635-001	8877248	2027-11-16	U-106	Drug product	2014-11-12
N201635-001	8877248	2027-11-16	U-1992	Drug product	2014-11-12
N201635-001	8889191	2027-11-16	U-106		2014-12-17
N201635-001	8889191	2027-11-16	U-1992		2014-12-17
N201635-001	8992989	2027-11-16	U-1675	Drug product	2015-04-08
N201635-001	8992989	2027-11-16	U-1992	Drug product	2015-04-08
N201635-001	9549940	2027-11-16	U-1675	Drug product	2017-01-27
N201635-001	9549940	2027-11-16	U-1992	Drug product	2017-01-27
N201635-001	9555004	2027-11-16	U-1675	Drug product	2017-02-09
N201635-001	9555004	2027-11-16	U-1992	Drug product	2017-02-09
N201635-001	9622983	2027-11-16	U-1675	Drug product	2017-04-20
N201635-001	9622983	2027-11-16	U-1992	Drug product	2017-04-20
N201635-001	8298576	2028-04-04	U-106	Drug product	2013-08-22
N201635-001	8298576	2028-04-04	U-1992	Drug product	2013-08-22
N201635-002	10314790	2027-11-16	U-1675	Drug product	2019-07-09
N201635-002	10314790	2027-11-16	U-1992	Drug product	2019-07-09
N201635-002	8298580	2027-11-16	U-106	Drug product	2013-08-22
N201635-002	8298580	2027-11-16	U-1992	Drug product	2013-08-22
N201635-002	8663683	2027-11-16	U-106	Drug product
N201635-002	8663683	2027-11-16	U-1992	Drug product
N201635-002	8877248	2027-11-16	U-106	Drug product	2014-11-12
N201635-002	8877248	2027-11-16	U-1992	Drug product	2014-11-12
N201635-002	8889191	2027-11-16	U-106		2014-12-17
N201635-002	8889191	2027-11-16	U-1992		2014-12-17
N201635-002	8992989	2027-11-16	U-1675	Drug product	2015-04-08
N201635-002	8992989	2027-11-16	U-1992	Drug product	2015-04-08
N201635-002	9549940	2027-11-16	U-1675	Drug product	2017-01-27
N201635-002	9549940	2027-11-16	U-1992	Drug product	2017-01-27
N201635-002	9555004	2027-11-16	U-1675	Drug product	2017-02-09
N201635-002	9555004	2027-11-16	U-1992	Drug product	2017-02-09
N201635-002	9622983	2027-11-16	U-1675	Drug product	2017-04-20
N201635-002	9622983	2027-11-16	U-1992	Drug product	2017-04-20
N201635-002	8298576	2028-04-04	U-106	Drug product	2013-08-22
N201635-002	8298576	2028-04-04	U-1992	Drug product	2013-08-22
N201635-003	10314790	2027-11-16	U-1675	Drug product	2019-07-09
N201635-003	10314790	2027-11-16	U-1992	Drug product	2019-07-09
N201635-003	8298580	2027-11-16	U-106	Drug product	2013-08-22
N201635-003	8298580	2027-11-16	U-1992	Drug product	2013-08-22
N201635-003	8663683	2027-11-16	U-106	Drug product
N201635-003	8663683	2027-11-16	U-1992	Drug product
N201635-003	8877248	2027-11-16	U-106	Drug product	2014-11-12
N201635-003	8877248	2027-11-16	U-1992	Drug product	2014-11-12
N201635-003	8889191	2027-11-16	U-106		2014-12-17
N201635-003	8889191	2027-11-16	U-1992		2014-12-17
N201635-003	8992989	2027-11-16	U-1675	Drug product	2015-04-08
N201635-003	8992989	2027-11-16	U-1992	Drug product	2015-04-08
N201635-003	9549940	2027-11-16	U-1675	Drug product	2017-01-27
N201635-003	9549940	2027-11-16	U-1992	Drug product	2017-01-27
N201635-003	9555004	2027-11-16	U-1675	Drug product	2017-02-09
N201635-003	9555004	2027-11-16	U-1992	Drug product	2017-02-09
N201635-003	9622983	2027-11-16	U-1675	Drug product	2017-04-20
N201635-003	9622983	2027-11-16	U-1992	Drug product	2017-04-20
N201635-003	8298576	2028-04-04	U-106	Drug product	2013-08-22
N201635-003	8298576	2028-04-04	U-1992	Drug product	2013-08-22
N201635-004	10314790	2027-11-16	U-1675	Drug product	2019-07-09
N201635-004	10314790	2027-11-16	U-1992	Drug product	2019-07-09
N201635-004	8298580	2027-11-16	U-106	Drug product	2013-08-22
N201635-004	8298580	2027-11-16	U-1992	Drug product	2013-08-22
N201635-004	8663683	2027-11-16	U-106	Drug product
N201635-004	8663683	2027-11-16	U-1992	Drug product
N201635-004	8877248	2027-11-16	U-106	Drug product	2014-11-12
N201635-004	8877248	2027-11-16	U-1992	Drug product	2014-11-12
N201635-004	8889191	2027-11-16	U-106		2014-12-17
N201635-004	8889191	2027-11-16	U-1992		2014-12-17
N201635-004	8992989	2027-11-16	U-1675	Drug product	2015-04-08
N201635-004	8992989	2027-11-16	U-1992	Drug product	2015-04-08
N201635-004	9549940	2027-11-16	U-1675	Drug product	2017-01-27
N201635-004	9549940	2027-11-16	U-1992	Drug product	2017-01-27
N201635-004	9555004	2027-11-16	U-1675	Drug product	2017-02-09
N201635-004	9555004	2027-11-16	U-1992	Drug product	2017-02-09
N201635-004	9622983	2027-11-16	U-1675	Drug product	2017-04-20
N201635-004	9622983	2027-11-16	U-1992	Drug product	2017-04-20
N201635-004	8298576	2028-04-04	U-106	Drug product	2013-08-22
N201635-004	8298576	2028-04-04	U-1992	Drug product	2013-08-22

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 5 · 172 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	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	N201635-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201635-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201635-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201635-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-004	AB1	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 86 · 3,440 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	N201635-001	10314790	2027-11-16	U-1675	Drug product	2019-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	10314790	2027-11-16	U-1992	Drug product	2019-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8298580	2027-11-16	U-1992	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8298580	2027-11-16	U-106	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8663683	2027-11-16	U-1992	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8663683	2027-11-16	U-106	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8877248	2027-11-16	U-1992	Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8877248	2027-11-16	U-106	Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8889191	2027-11-16	U-106		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8889191	2027-11-16	U-1992		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8992989	2027-11-16	U-1675	Drug product	2015-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8992989	2027-11-16	U-1992	Drug product	2015-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9549940	2027-11-16	U-1992	Drug product	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9549940	2027-11-16	U-1675	Drug product	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9555004	2027-11-16	U-1992	Drug product	2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9555004	2027-11-16	U-1675	Drug product	2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9622983	2027-11-16	U-1992	Drug product	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9622983	2027-11-16	U-1675	Drug product	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8298576	2028-04-04	U-106	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8298576	2028-04-04	U-1992	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	10314790	2027-11-16	U-1992	Drug product	2019-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	10314790	2027-11-16	U-1675	Drug product	2019-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8298580	2027-11-16	U-106	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8298580	2027-11-16	U-1992	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8663683	2027-11-16	U-106	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8663683	2027-11-16	U-1992	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8877248	2027-11-16	U-1992	Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8877248	2027-11-16	U-106	Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8889191	2027-11-16	U-106		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8889191	2027-11-16	U-1992		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8992989	2027-11-16	U-1675	Drug product	2015-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8992989	2027-11-16	U-1992	Drug product	2015-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9549940	2027-11-16	U-1992	Drug product	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9549940	2027-11-16	U-1675	Drug product	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9555004	2027-11-16	U-1992	Drug product	2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9555004	2027-11-16	U-1675	Drug product	2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9622983	2027-11-16	U-1992	Drug product	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9622983	2027-11-16	U-1675	Drug product	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8298576	2028-04-04	U-1992	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8298576	2028-04-04	U-106	Drug product	2013-08-22	`84e616aacf4f…`

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: Trokendi XR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOPIRAMATE	50 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedc	Product name	4	20260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077	Product name	2	20250623
cb966f54-bbf0-40fb-b581-80c6648d510c	Product name	4	20250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193	Product name	4	20250305
3d272a3f-17c0-421d-bc43-3cbdb719258d	Product name	1	20250303
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17772-102-01	Trokendi XR	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	29
17772-102-07	Trokendi XR	7 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	7	29
17772-102-10	Trokendi XR	5 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	5	29
17772-102-12	Trokendi XR	7 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	7	29
17772-102-15	Trokendi XR	30 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	30	29
17772-102-30	Trokendi XR	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	29
17772-102-70	Trokendi XR	7 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	7	29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17772-102-01	EA - Each	17772-102	b50aa032-0ece-4054-9431-844df08cefa9	1	2014-11-05
17772-102-15	EA - Each	17772-102	b3a4ef7e-904e-4dd4-be63-e034773a1b07	1	2013-10-17
17772-102-30	EA - Each	17772-102	a47ac3e6-e8a3-4d17-bc57-aaf64f4a30db	1	2017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
topiramate	ACTIVE INGREDIENT	0H73WJJ391	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
topiramate	ACTIVE MOIETY	0H73WJJ391	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
docusate sodium/sodium benzoate	INACTIVE INGREDIENT	656HXR6YXN	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
FD&C Red No. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Mannitol	INACTIVE INGREDIENT	3OWL53L36A	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Medium-Chain Triglycerides	INACTIVE INGREDIENT	C9H2L21V7U	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Oleic Acid	INACTIVE INGREDIENT	2UMI9U37CP	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Polyvinyl Alcohol	INACTIVE INGREDIENT	532B59J990	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Riboflavin	INACTIVE INGREDIENT	TLM2976OFR	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17772-102	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS]	25	Current NDC, Legacy NDC, 7 package rows	20250316_2dc7957e-a3e5-46bb-aa66-f3250f872f5e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0H73WJJ391	TOPIRAMATE	97240-79-4	TOPIRAMATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1437283	topiramate 100 MG 24HR Extended Release Oral Capsule	PSN	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437288	topiramate 200 MG 24HR Extended Release Oral Capsule	PSN	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437278	topiramate 25 MG 24HR Extended Release Oral Capsule	PSN	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1436239	topiramate 50 MG 24HR Extended Release Oral Capsule	PSN	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1436245	Trokendi 50 MG 24HR Extended Release Oral Capsule	PSN	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437285	Trokendi XR 100 MG 24HR Extended Release Oral Capsule	PSN	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437290	Trokendi XR 200 MG 24HR Extended Release Oral Capsule	PSN	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437280	Trokendi XR 25 MG 24HR Extended Release Oral Capsule	PSN	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437285	24 HR topiramate 100 MG Extended Release Oral Capsule [Trokendi]	SBD	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437290	24 HR topiramate 200 MG Extended Release Oral Capsule [Trokendi]	SBD	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437280	24 HR topiramate 25 MG Extended Release Oral Capsule [Trokendi]	SBD	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1436245	24 HR topiramate 50 MG Extended Release Oral Capsule [Trokendi]	SBD	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437283	24 HR topiramate 100 MG Extended Release Oral Capsule	SCD	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437288	24 HR topiramate 200 MG Extended Release Oral Capsule	SCD	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437278	24 HR topiramate 25 MG Extended Release Oral Capsule	SCD	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1436239	24 HR topiramate 50 MG Extended Release Oral Capsule	SCD	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437285	24 HR Trokendi 100 MG Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437290	24 HR Trokendi 200 MG Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437280	24 HR Trokendi 25 MG Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1436245	24 HR Trokendi XR 50 MG Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437283	topiramate 100 MG 24 HR Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437288	topiramate 200 MG 24 HR Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437278	topiramate 25 MG 24 HR Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1436239	topiramate 50 MG 24 HR Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437285	Trokendi XR 100 MG 24 HR Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437290	Trokendi XR 200 MG 24 HR Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1437280	Trokendi XR 25 MG 24 HR Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29
1436245	Trokendi XR 50 MG 24 HR Extended Release Oral Capsule	SY	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17772-102-01	17772010201	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-01)	2013-08-16	0000-00-00	No	No	Current
17772-102-07	17772010207	7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-07)	2020-06-23	0000-00-00	Yes	No	Current
17772-102-10	17772010210	5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-10)	2013-08-16	0000-00-00	Yes	No	Current
17772-102-12	17772010212	7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-12)	2013-08-16	0000-00-00	Yes	No	Current
17772-102-15	17772010215	30 in 1 BLISTER PACK					Historical
17772-102-30	17772010230	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-30)	2013-08-16	0000-00-00	No	No	Current
17772-102-70	17772010270	7 in 1 BOTTLE					Historical