QUDEXY

Product NDC: 0245-1075
11-digit product format: 002451075
Labeler code: 0245
Product ID: 0245-1075_c282e476-f752-48da-ae0f-2987d682a4b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: NDA205122
Marketing category: NDA
Marketing start: 2014-04-11
Substance: TOPIRAMATE
Active strength: 150 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205122-001	QUDEXY XR	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11
N205122-002	QUDEXY XR	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11
N205122-003	QUDEXY XR	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11
N205122-004	QUDEXY XR	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11
N205122-005	QUDEXY XR	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N205122-001	AB2
N205122-002	AB2
N205122-003	AB2
N205122-004	AB2
N205122-005	AB2

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205122-001	10363224	2033-03-19	U-766		2019-08-06
N205122-001	8652527	2033-03-19		Drug product	2014-03-12
N205122-001	8889190	2033-03-19		Drug product	2014-11-18
N205122-001	9101545	2033-03-19		Drug product	2015-08-11
N205122-001	9555005	2033-03-19		Drug product	2017-02-02
N205122-002	10363224	2033-03-19	U-766		2019-08-06
N205122-002	8652527	2033-03-19		Drug product	2014-03-12
N205122-002	8889190	2033-03-19		Drug product	2014-11-18
N205122-002	9101545	2033-03-19		Drug product	2015-08-11
N205122-002	9555005	2033-03-19		Drug product	2017-02-02
N205122-003	10363224	2033-03-19	U-766		2019-08-06
N205122-003	8652527	2033-03-19		Drug product	2014-03-12
N205122-003	8889190	2033-03-19		Drug product	2014-11-18
N205122-003	9101545	2033-03-19		Drug product	2015-08-11
N205122-003	9555005	2033-03-19		Drug product	2017-02-02
N205122-004	10363224	2033-03-19	U-766		2019-08-06
N205122-004	8652527	2033-03-19		Drug product	2014-03-12
N205122-004	8889190	2033-03-19		Drug product	2014-11-18
N205122-004	9101545	2033-03-19		Drug product	2015-08-11
N205122-004	9555005	2033-03-19		Drug product	2017-02-02
N205122-005	10363224	2033-03-19	U-766		2019-08-06
N205122-005	8652527	2033-03-19		Drug product	2014-03-12
N205122-005	8889190	2033-03-19		Drug product	2014-11-18
N205122-005	9101545	2033-03-19		Drug product	2015-08-11
N205122-005	9555005	2033-03-19		Drug product	2017-02-02

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 6 · 205 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	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 199 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	N205122-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-005	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205122-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-005	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-005	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-005	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-004	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-005	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-004	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-005	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-003	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-004	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-005	AB2	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,020 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	N205122-001	10363224	2033-03-19	U-766		2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-001	8652527	2033-03-19		Drug product	2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-001	8889190	2033-03-19		Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-001	9101545	2033-03-19		Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-001	9555005	2033-03-19		Drug product	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	10363224	2033-03-19	U-766		2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	8652527	2033-03-19		Drug product	2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	8889190	2033-03-19		Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	9101545	2033-03-19		Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	9555005	2033-03-19		Drug product	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	10363224	2033-03-19	U-766		2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	8652527	2033-03-19		Drug product	2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	8889190	2033-03-19		Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	9101545	2033-03-19		Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	9555005	2033-03-19		Drug product	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	10363224	2033-03-19	U-766		2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	8652527	2033-03-19		Drug product	2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	8889190	2033-03-19		Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	9101545	2033-03-19		Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	9555005	2033-03-19		Drug product	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	10363224	2033-03-19	U-766		2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	8652527	2033-03-19		Drug product	2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	8889190	2033-03-19		Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	9101545	2033-03-19		Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	9555005	2033-03-19		Drug product	2017-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	10363224	2033-03-19	U-766		2019-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	8652527	2033-03-19		Drug product	2014-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	8889190	2033-03-19		Drug product	2014-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	9101545	2033-03-19		Drug product	2015-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	9555005	2033-03-19		Drug product	2017-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	10363224	2033-03-19	U-766		2019-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	8652527	2033-03-19		Drug product	2014-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	8889190	2033-03-19		Drug product	2014-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	9101545	2033-03-19		Drug product	2015-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	9555005	2033-03-19		Drug product	2017-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	10363224	2033-03-19	U-766		2019-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	8652527	2033-03-19		Drug product	2014-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	8889190	2033-03-19		Drug product	2014-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	9101545	2033-03-19		Drug product	2015-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	9555005	2033-03-19		Drug product	2017-02-02	`31067a03dcf5…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUDEXY XR	TOPIRAMATE	Upsher-Smith Laboratories, LLC	46f54677-3a22-4c38-9b92-923020164e15	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205122 application number: NDA205122 ndc (product): 0245-1075
Topiramate	TOPIRAMATE	Upsher-Smith Laboratories, LLC	691d276c-9cc1-4d39-828f-0f44d7ef6328	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205122 application number: NDA205122

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOPIRAMATE	150 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 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1494766	Internal RxNorm lookup
1494769	Internal RxNorm lookup
1494771	Internal RxNorm lookup
1494775	Internal RxNorm lookup
1494778	Internal RxNorm lookup
1494781	Internal RxNorm lookup
1812419	Internal RxNorm lookup
1812421	Internal RxNorm lookup
1812425	Internal RxNorm lookup
1812427	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
46f54677-3a22-4c38-9b92-923020164e15	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0245-1075-30	QUDEXY XR	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	29
0245-1075-30	QUDEXY XR	1 in 1 CARTON	CAPSULE, EXTENDED RELEASE	1	29
0245-1075-90	QUDEXY XR	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	29
0245-1075-90	QUDEXY XR	1 in 1 CARTON	CAPSULE, EXTENDED RELEASE	1	29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0245-1075-15	EA - Each	0245-1075	d62bc738-729c-4808-ac2a-ea720b92594f	1	2014-07-02
0245-1075-30	EA - Each	0245-1075	00e04e5c-8d74-4fdd-aecc-609ea98f8e4b	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Topiramate	ACTIVE INGREDIENT	0H73WJJ391	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]	6
Topiramate	ACTIVE MOIETY	0H73WJJ391	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]	6
diethyl phthalate	INACTIVE INGREDIENT	UF064M00AF	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]	6
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]	6
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]	6
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]	6
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]	6
hypromellose 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0245-1075	QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE QUDEXY XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]	27	Current NDC, Legacy NDC, 4 package rows	20250519_46f54677-3a22-4c38-9b92-923020164e15.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
1494766	Qudexy XR 100 MG 24HR Extended Release Oral Capsule	PSN	46f54677-3a22-4c38-9b92-923020164e15	29
1494771	Qudexy XR 150 MG 24HR Extended Release Oral Capsule	PSN	46f54677-3a22-4c38-9b92-923020164e15	29
1494775	Qudexy XR 200 MG 24HR Extended Release Oral Capsule	PSN	46f54677-3a22-4c38-9b92-923020164e15	29
1494778	Qudexy XR 25 MG 24HR Extended Release Oral Capsule	PSN	46f54677-3a22-4c38-9b92-923020164e15	29
1494781	Qudexy XR 50 MG 24HR Extended Release Oral Capsule	PSN	46f54677-3a22-4c38-9b92-923020164e15	29
1812427	topiramate 100 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	46f54677-3a22-4c38-9b92-923020164e15	29
1494769	topiramate 150 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	46f54677-3a22-4c38-9b92-923020164e15	29
1812419	topiramate 200 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	46f54677-3a22-4c38-9b92-923020164e15	29
1812421	topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	46f54677-3a22-4c38-9b92-923020164e15	29
1812425	topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	46f54677-3a22-4c38-9b92-923020164e15	29
1494766	Sprinkle 24 HR topiramate 100 MG Extended Release Oral Capsule [Qudexy]	SBD	46f54677-3a22-4c38-9b92-923020164e15	29
1494771	Sprinkle 24 HR topiramate 150 MG Extended Release Oral Capsule [Qudexy]	SBD	46f54677-3a22-4c38-9b92-923020164e15	29
1494775	Sprinkle 24 HR topiramate 200 MG Extended Release Oral Capsule [Qudexy]	SBD	46f54677-3a22-4c38-9b92-923020164e15	29
1494778	Sprinkle 24 HR topiramate 25 MG Extended Release Oral Capsule [Qudexy]	SBD	46f54677-3a22-4c38-9b92-923020164e15	29
1494781	Sprinkle 24 HR topiramate 50 MG Extended Release Oral Capsule [Qudexy]	SBD	46f54677-3a22-4c38-9b92-923020164e15	29
1812427	Sprinkle 24 HR topiramate 100 MG Extended Release Oral Capsule	SCD	46f54677-3a22-4c38-9b92-923020164e15	29
1494769	Sprinkle 24 HR topiramate 150 MG Extended Release Oral Capsule	SCD	46f54677-3a22-4c38-9b92-923020164e15	29
1812419	Sprinkle 24 HR topiramate 200 MG Extended Release Oral Capsule	SCD	46f54677-3a22-4c38-9b92-923020164e15	29
1812421	Sprinkle 24 HR topiramate 25 MG Extended Release Oral Capsule	SCD	46f54677-3a22-4c38-9b92-923020164e15	29
1812425	Sprinkle 24 HR topiramate 50 MG Extended Release Oral Capsule	SCD	46f54677-3a22-4c38-9b92-923020164e15	29
1494766	Qudexy XR 100 MG 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1494766	Qudexy XR 100 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1494771	Qudexy XR 150 MG 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1494771	Qudexy XR 150 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1494775	Qudexy XR 200 MG 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1494775	Qudexy XR 200 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1494778	Qudexy XR 25 MG 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1494778	Qudexy XR 25 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1494781	Qudexy XR 50 MG 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1494781	Qudexy XR 50 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1812427	topiramate 100 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1494769	topiramate 150 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1812419	topiramate 200 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1812421	topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29
1812425	topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule	SY	46f54677-3a22-4c38-9b92-923020164e15	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0245-1075-30	00245107530	1 BOTTLE in 1 CARTON (0245-1075-30) / 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2014-04-11	0000-00-00	No	No	Current
0245-1075-90	00245107590	1 BOTTLE in 1 CARTON (0245-1075-90) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2014-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QUDEXY XR	Upsher-Smith Laboratories, LLC \| Catalent Pharma Solutions, LLC	2026-03-26	HUMAN PRESCRIPTION DRUG LABEL	29