Topiramate

Product NDC: 80425-0202
11-digit product format: 804250202
Labeler code: 80425
Product ID: 80425-0202_ed392b6a-91d2-0d86-e053-2995a90ab8c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA078462
Marketing category: ANDA
Marketing start: 2009-03-27
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	80425-0202		D	Discontinued by firm		2026-08-03
excluded package	package	80425-0202	80425-0202-2	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078462-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A078462-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A078462-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A078462-004	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
A078462-001	AB
A078462-002	AB
A078462-003	AB
A078462-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A078462-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078462-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078462-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078462-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078462-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078462-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078462-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078462-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078462-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078462-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078462-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078462-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078462-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078462-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078462-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078462-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078462-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078462-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078462-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078462-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078462-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078462-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078462-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078462-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078462-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078462-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078462-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078462-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078462-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078462-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078462-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078462-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078462-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078462-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078462-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078462-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078462-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078462-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078462-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078462-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078462-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078462-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078462-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078462-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078462-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078462-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078462-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078462-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078462-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078462-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078462-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078462-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078462-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078462-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078462-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078462-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078462-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078462-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078462-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078462-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078462-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078462-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078462-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078462-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078462-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078462-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078462-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078462-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078462-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078462-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078462-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078462-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078462-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078462-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078462-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078462-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078462-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078462-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078462-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078462-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	PD-Rx Pharmaceuticals, Inc.	4833f2e8-16b7-406f-937a-55bc978bf92c	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078462 application number: ANDA078462
Topiramate	TOPIRAMATE	Aurobindo Pharma Limited	32b48ea0-a215-43b8-83b4-a5435a686d68	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078462 application number: ANDA078462
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	5424d59e-74f1-4c3c-b737-79e9776e0b60	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078462 application number: ANDA078462
Topiramate	TOPIRAMATE	NCS HealthCare of KY, LLC dba Vangard Labs	444464fb-6a95-4e10-99a7-fdbc7dbb4c48	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078462 application number: ANDA078462

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0202-2	EA - Each	80425-0202	d55a9c3a-bd50-4971-9d84-af2dd7827a5f	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0202	TOPIRAMATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	3	Legacy NDC	20250101_ed3932cc-06b7-23d0-e053-2995a90a4773.zip

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	Marketing end	Sample	Exclude flag	Status
80425-0202-2	80425020202	30 TABLET, FILM COATED in 1 BOTTLE (80425-0202-2)	2009-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topiramate Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	3