topiramate

Product NDC: 50090-5853
11-digit product format: 500905853
Labeler code: 50090
Product ID: 50090-5853_4ed19ca8-e239-41ce-afc3-4211caa41781
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078235
Marketing category: ANDA
Marketing start: 2009-03-27
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: 2026-12-31
Current FDA listing: Yes

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A078235-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078235-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078235-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078235-004	AB	1	`a50c72e98297…`

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

Additional Listing Data#

Finished product: Yes
Brand name base: topiramate
Listing expiration: 2026-12-31

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
f7f2d1bc-9c65-4798-826f-6902b3ec81dc	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5853-0	2023-02-07	C162847	48780-1	f386c64a-370e-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
50090-5853-1	2023-02-07	C162847	48780-1	f386c64a-370e-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
50090-5853-2	2023-02-07	C162847	48780-1	f386c64a-370e-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
50090-5853-0	2023-01-30	C162847	48780-1	f386c64a-370e-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
50090-5853-1	2023-01-30	C162847	48780-1	f386c64a-370e-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996
50090-5853-2	2023-01-30	C162847	48780-1	f386c64a-370e-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TOPIRAMATE safely and effectively. See full prescribing information for TOPIRAMATE. TOPIRAMATE tablets, for oral use TOPIRAMATE capsules, for oral use Initial U.S. Approval-1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-5853-0	topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60	5
50090-5853-1	topiramate	90 in 1 BOTTLE	TABLET, FILM COATED	90	5
50090-5853-2	topiramate	30 in 1 BOTTLE	TABLET, FILM COATED	30	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5853-0	EA - Each	50090-5853	ded97157-d9e4-4310-afb4-e895f7bc2d7b	1	2022-04-06
50090-5853-1	EA - Each	50090-5853	4e1d321b-02fa-44c3-b55a-7799daab25ad	1	2022-06-06
50090-5853-2	EA - Each	50090-5853	1120f31c-b222-4bc4-bab5-8143de1e7307	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5853	TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	5	Current NDC, Legacy NDC, 3 package rows	20231125_f7f2d1bc-9c65-4798-826f-6902b3ec81dc.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199888	topiramate 25 MG Oral Tablet	PSN	f7f2d1bc-9c65-4798-826f-6902b3ec81dc	5
199888	topiramate 25 MG Oral Tablet	SCD	f7f2d1bc-9c65-4798-826f-6902b3ec81dc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5853-0	50090585300	60 TABLET, FILM COATED in 1 BOTTLE (50090-5853-0)	2021-11-10	0000-00-00	No	No	Current
50090-5853-1	50090585301	90 TABLET, FILM COATED in 1 BOTTLE (50090-5853-1)	2021-11-10	0000-00-00	No	No	Current
50090-5853-2	50090585302	30 TABLET, FILM COATED in 1 BOTTLE (50090-5853-2)	2021-11-10	0000-00-00	No	No	Current