Trokendi XR

Product NDC: 17772-103
Requested package NDC: 17772-103-01
11-digit product format: 177720103
Labeler code: 17772
Product ID: 17772-103_4d7bcc14-c816-0b67-e063-6394a90a1097
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: 100 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 164 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201635-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201635-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201635-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201635-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201635-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201635-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201635-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201635-004	AB1	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 82 · 3,280 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	N201635-001	10314790	2027-11-16	U-1675	Drug product	2019-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	10314790	2027-11-16	U-1992	Drug product	2019-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8298580	2027-11-16	U-1992	Drug product	2013-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8298580	2027-11-16	U-106	Drug product	2013-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8663683	2027-11-16	U-1992	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8663683	2027-11-16	U-106	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8877248	2027-11-16	U-1992	Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8877248	2027-11-16	U-106	Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8889191	2027-11-16	U-106		2014-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8889191	2027-11-16	U-1992		2014-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8992989	2027-11-16	U-1675	Drug product	2015-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8992989	2027-11-16	U-1992	Drug product	2015-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	9549940	2027-11-16	U-1992	Drug product	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	9549940	2027-11-16	U-1675	Drug product	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	9555004	2027-11-16	U-1992	Drug product	2017-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	9555004	2027-11-16	U-1675	Drug product	2017-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	9622983	2027-11-16	U-1992	Drug product	2017-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	9622983	2027-11-16	U-1675	Drug product	2017-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8298576	2028-04-04	U-106	Drug product	2013-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-001	8298576	2028-04-04	U-1992	Drug product	2013-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	10314790	2027-11-16	U-1992	Drug product	2019-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	10314790	2027-11-16	U-1675	Drug product	2019-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8298580	2027-11-16	U-106	Drug product	2013-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8298580	2027-11-16	U-1992	Drug product	2013-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8663683	2027-11-16	U-106	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8663683	2027-11-16	U-1992	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8877248	2027-11-16	U-1992	Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8877248	2027-11-16	U-106	Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8889191	2027-11-16	U-106		2014-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8889191	2027-11-16	U-1992		2014-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8992989	2027-11-16	U-1675	Drug product	2015-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8992989	2027-11-16	U-1992	Drug product	2015-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	9549940	2027-11-16	U-1992	Drug product	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	9549940	2027-11-16	U-1675	Drug product	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	9555004	2027-11-16	U-1992	Drug product	2017-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	9555004	2027-11-16	U-1675	Drug product	2017-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	9622983	2027-11-16	U-1992	Drug product	2017-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	9622983	2027-11-16	U-1675	Drug product	2017-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8298576	2028-04-04	U-1992	Drug product	2013-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	8298576	2028-04-04	U-106	Drug product	2013-08-22	`011fe1cb6892…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOPIRAMATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0H73WJJ391	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1436239	Internal RxNorm lookup
1436245	Internal RxNorm lookup
1437278	Internal RxNorm lookup
1437280	Internal RxNorm lookup
1437283	Internal RxNorm lookup
1437285	Internal RxNorm lookup
1437288	Internal RxNorm lookup
1437290	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
2dc7957e-a3e5-46bb-aa66-f3250f872f5e	Available on FDA.report

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
17772-103-01	Trokendi XR	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	29
17772-103-07	Trokendi XR	7 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	7	29
17772-103-10	Trokendi XR	5 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	5	29
17772-103-12	Trokendi XR	7 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	7	29
17772-103-15	Trokendi XR	30 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	30	29
17772-103-30	Trokendi XR	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	29
17772-103-70	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
17772-103-01	EA - Each	17772-103	308399cb-b759-4cc1-99af-e61c585fe9ab	1	2014-11-05
17772-103-15	EA - Each	17772-103	02db438c-4cb0-4e08-90ab-373545677529	1	2013-10-17
17772-103-30	EA - Each	17772-103	745a1173-91a1-4275-a426-953035b735a8	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
17772-103	TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS]	25	Current NDC, Legacy NDC, 7 package rows	20250316_2dc7957e-a3e5-46bb-aa66-f3250f872f5e.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
Trokendi XR	TOPIRAMATE	Supernus Pharmaceuticals, Inc.	2dc7957e-a3e5-46bb-aa66-f3250f872f5e	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201635 application number: NDA201635 ndc (package): 17772-103-01 ndc (product): 17772-103 ndc11 (package): 17772010301

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
17772-103-01	17772010301	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-01)	2013-08-16	0000-00-00	No	No	Current