Topiramate

Product NDC: 63629-6871
Requested package NDC: 63629-6871-1
11-digit product format: 636296871
Labeler code: 63629
Product ID: 63629-6871_cc1d0a52-17eb-4934-b283-6fac3057e955
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076575
Marketing category: ANDA
Marketing start: 2009-04-17
Marketing end: 0000-00-00
Substance: TOPIRAMATE
Active strength: 15 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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-6871	63629-6871-1	D	Discontinued by firm		2026-08-03

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076575-001	TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE / ORAL			2009-04-17
A076575-002	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE / ORAL			2009-04-17

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL		2009-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL		2009-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076575-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076575-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-04-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076575-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076575-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076575-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076575-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076575-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076575-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076575-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076575-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076575-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076575-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076575-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076575-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076575-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076575-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076575-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076575-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076575-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076575-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076575-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076575-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076575-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076575-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076575-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076575-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076575-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076575-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076575-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076575-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076575-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076575-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076575-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076575-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076575-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076575-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076575-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076575-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076575-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076575-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076575-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076575-002	AB	1	`87673890dc5c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-6871-1	2020-10-16	These highlights do not include all the information needed to use TOPIRAMATE CAPSULES (SPRINKLE) safely and effectively. See full prescribing information for TOPIRAMATE CAPSULES (SPRINKLE). TOPIRAMATE capsules (sprinkle), for oral use Initial U.S. Approval: 1996
63629-6871-2	2020-10-16	These highlights do not include all the information needed to use TOPIRAMATE CAPSULES (SPRINKLE) safely and effectively. See full prescribing information for TOPIRAMATE CAPSULES (SPRINKLE). TOPIRAMATE capsules (sprinkle), for oral use Initial U.S. Approval: 1996
63629-6871-1	2020-01-31	These highlights do not include all the information needed to use TOPIRAMATE CAPSULES (SPRINKLE) safely and effectively. See full prescribing information for TOPIRAMATE CAPSULES (SPRINKLE). TOPIRAMATE capsules (sprinkle), for oral use Initial U.S. Approval: 1996
63629-6871-2	2020-01-31	These highlights do not include all the information needed to use TOPIRAMATE CAPSULES (SPRINKLE) safely and effectively. See full prescribing information for TOPIRAMATE CAPSULES (SPRINKLE). TOPIRAMATE capsules (sprinkle), for oral use Initial U.S. Approval: 1996

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-6871-1	63629687101	30 CAPSULE, COATED PELLETS in 1 BOTTLE (63629-6871-1)	2022-02-08	0000-00-00	No	No	Current