topiramate

Product NDC: 67046-1691
Requested package NDC: 67046-1691-3
11-digit product format: 670461691
Labeler code: 67046
Product ID: 67046-1691_5826ca76-89b5-72b1-e063-6294a90a8468
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Coupler LLC
Application: ANDA090162
Marketing category: ANDA
Marketing start: 2026-08-03
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

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	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
5826cb22-3559-171b-e063-6394a90ad594	Available on FDA.report

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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	Coupler LLC	5826cb22-3559-171b-e063-6394a90ad594	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162 ndc (package): 67046-1691-3 ndc (product): 67046-1691 ndc11 (package): 67046169103
topiramate	TOPIRAMATE	Bryant Ranch Prepack	12cd9be8-c5c2-4a16-9164-87963e22a88e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Coupler LLC	52ba9c4f-e7d0-4352-e063-6394a90af7e2	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Coupler LLC	50b10a3d-883c-8891-e063-6394a90a86a1	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Unichem Pharmaceuticals (USA), Inc.	6ee00e82-799d-445e-b658-a9712c49a28e	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	4b1d3130-cf3c-d7da-e063-6294a90a6079	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	68b22d22-c2d3-4e90-b302-56f7cb731427	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	A-S Medication Solutions	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	A-S Medication Solutions	c6918801-f22c-4ba4-a396-da484d4334ca	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	49701840-5a32-4ac1-8b07-5c61decacb95	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	bf732c34-9078-496a-8093-f68594e76fcb	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	02cac021-e135-483f-bb5d-f3696eef0682	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	c320999e-b940-44d8-bf31-2fb78835ac2d	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	073d075d-d019-4834-b55d-9b9587914975	2025-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	30ca2fce-4e4c-439e-e063-6294a90af076	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	bbf0f882-1dcc-415d-82bb-acc64f4dc2bc	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	288d6b40-8c87-4f16-85a7-86166b5ac77f	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	2cf7ce9e-afc2-f94e-e063-6394a90a35d0	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	521be3f1-3ee7-45c7-9f0c-17e08b6c8fca	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	f16065c0-9949-9ac4-e053-2995a90a3b02	2024-12-31	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-1691-3	67046169103	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1691-3)	2026-08-03	No	No	Current