topiramate

Product NDC: 60760-752
11-digit product format: 607600752
Labeler code: 60760
Product ID: 60760-752_5b864f00-1e9e-5098-e063-6394a90a6967
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA090162
Marketing category: ANDA
Marketing start: 2025-12-23
Substance: TOPIRAMATE
Active strength: 25 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 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
A090162-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A090162-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A090162-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A090162-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090162-001	AB
A090162-002	AB
A090162-003	AB
A090162-004	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	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`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	A090162-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090162-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090162-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090162-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090162-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090162-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090162-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090162-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090162-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090162-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-004	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	25 mg/1

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	Strength	SPL version
60760-752-60	topiramate	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-752-60	EA - Each	60760-752	788d50bc-55f6-4b32-9525-30d4183b94a7	1	2026-01-08

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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	f781ada8-f90d-b233-e053-6394a90a87ff	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	A-S Medication Solutions	8706a35d-5c39-4daf-b83a-65f3d630e043	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	654f7c48-8c5d-4b97-88d6-397696f82b6a	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	1ef1c408-30f7-51ee-e063-6394a90ac880	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	816566bf-b909-606f-e053-2a91aa0ab8c9	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Proficient Rx LP	cc918c0d-2b1e-4fa0-b4d3-9dbc28718018	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Proficient Rx LP	584e16c5-5ffb-4bfc-ba80-4340afd25e8e	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Proficient Rx LP	2d6d236b-9808-4e18-b521-e7435d1fd5cc	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162

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
199888	topiramate 25 MG Oral Tablet	PSN	46a305cb-ab73-0bca-e063-6294a90a9b85	2
199888	topiramate 25 MG Oral Tablet	SCD	46a305cb-ab73-0bca-e063-6294a90a9b85	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
60760-752-30	60760075230	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-752-30)	2026-09-11	No	No	Current
60760-752-60	60760075260	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-752-60)	2025-12-23	No	No	Current
60760-752-90	60760075290	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-752-90)	2026-07-08	No	No	Current