Topiramate

Product NDC: 87441-079
11-digit product format: 874410079
Labeler code: 87441
Product ID: 87441-079_562f23fb-6df8-1df7-e063-6394a90a9c90
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Solutions, Inc.
Application: ANDA077627
Marketing category: ANDA
Marketing start: 2026-07-09
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
A077627-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A077627-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A077627-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A077627-004	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
A077627-001	AB
A077627-002	AB
A077627-003	AB
A077627-004	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	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-004	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	A077627-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077627-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077627-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077627-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077627-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077627-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077627-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077627-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077627-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077627-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077627-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077627-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077627-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077627-004	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

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
199888	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
562f3fec-489b-4662-e063-6294a90a4ea2	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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	3f99b26b-79b9-4efb-aa2c-2868e1e126c8	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	610d4df7-703f-4070-9adc-3e57ca05a2f1	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	Unit Dose Solutions, Inc.	562f3fec-489b-4662-e063-6294a90a4ea2	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627 ndc (product): 87441-079
Topiramate	TOPIRAMATE	Glenmark Pharmaceuticals Inc., USA	35312f49-decf-428d-bf5f-4215b762ed3c	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	Northwind Health Company, LLC	ae63e0e2-ceb1-4cc7-88fa-92cfa4516960	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	Proficient Rx LP	a712d050-d5de-4685-a80a-548ab080fdb7	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627
Topiramate	TOPIRAMATE	Proficient Rx LP	5d9b2c1d-565e-4c43-96ef-e5cd2593d0a8	2020-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077627 application number: ANDA077627

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
87441-079-01	87441007901	30 TABLET, FILM COATED in 1 BLISTER PACK (87441-079-01)	2026-07-09	No	No	Current