Topiramate

Product NDC: 71610-193
Requested package NDC: 71610-193-53
11-digit product format: 716100193
Labeler code: 71610
Product ID: 71610-193_8983a5e5-b9d5-40d1-8efb-8b3f8919cad2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA079162
Marketing category: ANDA
Marketing start: 2011-07-08
Marketing end: 0000-00-00
Substance: TOPIRAMATE
Active strength: 50 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	71610-193	71610-193-53	I	Inactivated by FDA		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 · 16 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	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
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…`
2022-08-30 03:57 UTC · source 2022-08-29	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`

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
A079162-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A079162-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A079162-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A079162-004	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
A079162-001	AB
A079162-002	AB
A079162-003	AB
A079162-004	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	A079162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079162-004	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	A079162-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079162-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079162-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079162-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079162-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079162-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079162-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079162-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079162-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079162-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079162-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079162-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079162-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079162-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079162-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079162-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079162-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079162-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079162-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079162-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079162-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079162-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079162-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079162-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079162-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079162-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079162-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079162-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079162-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079162-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079162-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079162-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079162-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079162-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079162-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079162-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079162-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079162-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079162-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079162-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71610-193-53	2023-01-30	C162847	48780-1	f386c64a-0f63-0266-e053-dadaa90a7c1a	TOPIRAMATE TABS These highlights do not include all the information needed to use [topiramate tablets, USP] safely and effectively. See full prescribing information for[topiramate tablets, USP] Initial U.S. Approval:[1996]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-193-53	Topiramate	60 in 1 BOTTLE	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-193-53	EA - Each	71610-193	c2c1cf5f-715b-4a9f-a8f6-220ded3398ab	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-193	TOPIRAMATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 1 package rows	20190109_7b630268-906b-4c75-bb98-99957e3a7072.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Cipla USA Inc.	4087eb3c-96e9-4d0a-b80b-663e1c86d256	2025-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079162 application number: ANDA079162
Topiramate	TOPIRAMATE	EXELAN PHARMACEUTICALS INC.	690baf58-1ec9-463e-99b7-d601362ea56b	2025-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079162 application number: ANDA079162
Topiramate	TOPIRAMATE	Aphena Pharma Solutions - Tennessee, LLC	3b18b43c-0de2-4acf-b0d5-f1b601d496de	2021-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079162 application number: ANDA079162
Topiramate	TOPIRAMATE	Proficient Rx LP	e9c4e279-0ef9-4e96-8741-dfe7556953d9	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079162 application number: ANDA079162

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
151226	topiramate 50 MG Oral Tablet	PSN	7b630268-906b-4c75-bb98-99957e3a7072	2
151226	topiramate 50 MG Oral Tablet	SCD	7b630268-906b-4c75-bb98-99957e3a7072	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-193-53	71610019353	60 TABLET in 1 BOTTLE (71610-193-53)	60 tablet	2018-11-13	0000-00-00	No	No	Current