TOPIRAMATE

Product NDC: 43602-458
11-digit product format: 436020458
Labeler code: 43602
Product ID: 43602-458_aae1df09-1482-4aef-a038-11295c610473
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET
Route: ORAL
Labeler: Ascent Pharmaceuticals, Inc.
Application: ANDA215414
Marketing category: ANDA
Marketing start: 2021-08-26
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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43602-458		D	Discontinued by firm	2026-10-05
excluded package	package	43602-458	43602-458-10	D	Discontinued by firm	2026-10-05
excluded package	package	43602-458	43602-458-30	D	Discontinued by firm	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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	43602-458		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43602-458	43602-458-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43602-458	43602-458-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A215414-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26
A215414-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26
A215414-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26
A215414-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215414-001	AB
A215414-002	AB
A215414-003	AB
A215414-004	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 4 · 140 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	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2021-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2021-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2021-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2021-08-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	A215414-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215414-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215414-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215414-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215414-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215414-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215414-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215414-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215414-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215414-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215414-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215414-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215414-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215414-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215414-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215414-004	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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43602-458	TOPIRAMATE TABLET [ASCENT PHARMACEUTICALS, INC.]	4	Legacy NDC	20210908_41a5a961-8756-464c-aef3-22f2c9047609.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOPIRAMATE	TOPIRAMATE	XLCare Pharmaceuticals, Inc.	546103e1-ea6e-466b-b0de-b1ff8c494512	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215414 application number: ANDA215414
TOPIRAMATE	TOPIRAMATE	Camber Pharmaceuticals, Inc.	cefbc5f4-ef5f-4732-ab96-a69a183f0b6b	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215414 application number: ANDA215414

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43602-458-10	43602045810	1000 TABLET in 1 BOTTLE (43602-458-10)	1000 tablet	2021-08-26	0000-00-00	No	No	Current
43602-458-30	43602045830	30 TABLET in 1 BOTTLE (43602-458-30)	30 tablet	2021-08-26	0000-00-00	No	No	Current