Topiramate

Product NDC: 0615-7565
11-digit product format: 006157565
Labeler code: 0615
Product ID: 0615-7565_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA078235
Marketing category: ANDA
Marketing start: 2009-03-27
Marketing end: 0000-00-00
Substance: TOPIRAMATE
Active strength: 200 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: E
Listing certified through: 2017-12-31
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	0615-7565		D	Discontinued by firm		2026-08-03
excluded package	package	0615-7565	0615-7565-39	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 16 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0615-7565		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7565	0615-7565-39	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	0615-7565		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0615-7565	0615-7565-39	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	0615-7565		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0615-7565	0615-7565-39	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	0615-7565		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0615-7565	0615-7565-39	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	0615-7565		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0615-7565	0615-7565-39	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	0615-7565		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7565	0615-7565-39	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	0615-7565		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7565	0615-7565-39	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	0615-7565		I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7565	0615-7565-39	I	Inactivated by FDA	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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
A078235-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A078235-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A078235-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A078235-004	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
A078235-001	AB
A078235-002	AB
A078235-003	AB
A078235-004	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	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078235-004	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	A078235-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078235-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078235-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078235-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078235-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078235-004	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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	REMEDYREPACK INC.	7e0834ee-920b-496f-954d-f9d81c3ba2d6	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	0366164b-1846-443d-9564-dbe52d8d9b65	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	St. Mary's Medical Park Pharmacy	92637f92-9d7c-c246-e053-2995a90a0347	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	St. Mary's Medical Park Pharmacy	9221403c-467f-738e-e053-2995a90ac8fd	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	8abe45eb-cc75-4625-ae3d-5b2a038c4907	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	bffcd213-4f09-4a5b-8ccb-591a68be402b	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	57462baf-2f32-4bde-9627-2214c8af9370	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	ca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Coupler LLC	5461f33d-eaef-dce3-e063-6294a90aeff8	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	AvPAK	53c3f980-f05b-c671-e063-6294a90a77d5	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	6f461f84-bfad-44fa-a2bd-5ea1566444b5	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	b7539f52-06e9-4663-b401-92f5f83653cc	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	5ce65b7f-9215-47a8-a784-f87a810bd7e4	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	149d20de-f262-4567-aa97-d4d28a1653cb	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Quallent Pharmaceuticals Health LLC	9dae6824-6913-42de-b98a-cdcb0d3b4a46	2026-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Zydus Pharmaceuticals USA Inc.	67dcdd6e-48bc-418e-a887-805929d83ce0	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Northwind Health Company, LLC	afd4c2b9-b80c-b43a-e053-2995a90ac923	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Northwind Health Company, LLC	f3321dc5-0fb7-0d12-e053-2a95a90a9694	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Northwind Health Company, LLC	ffd7be08-050e-dfcb-e053-6394a90ad286	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-7565-39	2022-10-03	C162847	48780-1	97449f38-c99b-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use topiramate safely and effectively. See full prescribing information for topiramate. Topiramate Tablets, USP Topiramate Capsules (Sprinkle) "Initial U.S. Approval:". 1996
0615-7565-39	2019-11-13	C162847	48780-1	97449f38-c99b-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use topiramate safely and effectively. See full prescribing information for topiramate. Topiramate Tablets, USP Topiramate Capsules (Sprinkle) "Initial U.S. Approval:". 1996

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0H73WJJ391	TOPIRAMATE	97240-79-4	TOPIRAMATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topiramate	NCS HealthCare of KY, Inc dba Vangard Labs	2012-08-23	HUMAN PRESCRIPTION DRUG LABEL	14