topiramate

Product NDC: 71335-1143
Requested package NDC: 71335-1143-2
11-digit product format: 713351143
Labeler code: 71335
Product ID: 71335-1143_e7100f13-3b70-4823-b5a8-1cafddb51f70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078235
Marketing category: ANDA
Marketing start: 2009-03-27
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

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	71335-1143	71335-1143-2	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 · 14 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…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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	Approval date
A078235-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A078235-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A078235-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A078235-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078235-001	AB
A078235-002	AB
A078235-003	AB
A078235-004	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`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	A078235-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078235-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078235-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078235-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-004	AB	1	`5bbf6a4d5a75…`

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: topiramate
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199889	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
bffcd213-4f09-4a5b-8ccb-591a68be402b	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71335-1143-1	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-1	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-2	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-2	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-3	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-3	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-4	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-4	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-5	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-5	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-6	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-6	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-7	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-7	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-8	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-8	2024-05-17	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-1	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-1	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-2	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-2	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-3	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-3	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-4	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-4	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-5	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-5	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-6	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-6	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-7	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-7	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-8	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
71335-1143-8	2024-01-30	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1143-1	topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60	102
71335-1143-2	topiramate	30 in 1 BOTTLE	TABLET, FILM COATED	30	102
71335-1143-3	topiramate	90 in 1 BOTTLE	TABLET, FILM COATED	90	102
71335-1143-4	topiramate	120 in 1 BOTTLE	TABLET, FILM COATED	120	102
71335-1143-5	topiramate	50 in 1 BOTTLE	TABLET, FILM COATED	50	102
71335-1143-6	topiramate	14 in 1 BOTTLE	TABLET, FILM COATED	14	102
71335-1143-7	topiramate	45 in 1 BOTTLE	TABLET, FILM COATED	45	102
71335-1143-8	topiramate	7 in 1 BOTTLE	TABLET, FILM COATED	7	102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1143-1	EA - Each	71335-1143	674f1aa8-bbdc-421c-a145-20e47e7318c9	1	2019-10-07
71335-1143-2	EA - Each	71335-1143	c9b23556-1cfb-40b9-8060-ebb268ddc591	1	2019-10-07
71335-1143-3	EA - Each	71335-1143	f743cbf7-51b0-4c01-83b8-26e91a540e9f	1	2019-10-07
71335-1143-4	EA - Each	71335-1143	01b47567-9c04-4ec4-8ff6-9f5b87e4b9bf	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1143	TOPIRAMATE TABLET, FILM COATED [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 8 package rows	20240518_bffcd213-4f09-4a5b-8ccb-591a68be402b.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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	Coupler LLC	59f39dea-f29b-d6c6-e063-6294a90a5b74	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	7e0834ee-920b-496f-954d-f9d81c3ba2d6	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	0366164b-1846-443d-9564-dbe52d8d9b65	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	St. Mary's Medical Park Pharmacy	92637f92-9d7c-c246-e053-2995a90a0347	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	St. Mary's Medical Park Pharmacy	9221403c-467f-738e-e053-2995a90ac8fd	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	8abe45eb-cc75-4625-ae3d-5b2a038c4907	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	bffcd213-4f09-4a5b-8ccb-591a68be402b	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235 ndc (package): 71335-1143-2 ndc (product): 71335-1143 ndc11 (package): 71335114302
topiramate	TOPIRAMATE	Bryant Ranch Prepack	57462baf-2f32-4bde-9627-2214c8af9370	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	ca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Coupler LLC	5461f33d-eaef-dce3-e063-6294a90aeff8	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	AvPAK	53c3f980-f05b-c671-e063-6294a90a77d5	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	6f461f84-bfad-44fa-a2bd-5ea1566444b5	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	b7539f52-06e9-4663-b401-92f5f83653cc	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	5ce65b7f-9215-47a8-a784-f87a810bd7e4	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	149d20de-f262-4567-aa97-d4d28a1653cb	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Quallent Pharmaceuticals Health LLC	9dae6824-6913-42de-b98a-cdcb0d3b4a46	2026-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Zydus Pharmaceuticals USA Inc.	67dcdd6e-48bc-418e-a887-805929d83ce0	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Northwind Health Company, LLC	afd4c2b9-b80c-b43a-e053-2995a90ac923	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Northwind Health Company, LLC	f3321dc5-0fb7-0d12-e053-2a95a90a9694	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235

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
199889	topiramate 100 MG Oral Tablet	PSN	bffcd213-4f09-4a5b-8ccb-591a68be402b	102
199889	topiramate 100 MG Oral Tablet	SCD	bffcd213-4f09-4a5b-8ccb-591a68be402b	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1143-2	71335114302	30 TABLET, FILM COATED in 1 BOTTLE (71335-1143-2)	2019-03-07	0000-00-00	No	No	Current