TOPIRAMATE TABLETS and TOPIRAMATE CAPSULES

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-14
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-05-31 21:10:43

Label at a glance#

Producttopiramate

Active ingredientTOPIRAMATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-647-14 in bottle of 60 tablets

Topiramate Tablets USP, 25 mg

60 tablets

Rx only

NDC 65841-648-14 in bottle of 60 tablets

Topiramate Tablets USP, 50 mg

60 tablets

Rx only

NDC 65841-649-14 in bottle of 60 tablets

Topiramate Tablets USP, 100 mg

60 tablets

Rx only

NDC 65841-650-14 in bottle of 60 tablets

Topiramate Tablets USP, 200 mg

60 tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
199889	topiramate 100 MG Oral Tablet	PSN	9
199890	topiramate 200 MG Oral Tablet	PSN	9
199888	topiramate 25 MG Oral Tablet	PSN	9
151226	topiramate 50 MG Oral Tablet	PSN	9
199889	topiramate 100 MG Oral Tablet	SCD	9
199890	topiramate 200 MG Oral Tablet	SCD	9
199888	topiramate 25 MG Oral Tablet	SCD	9
151226	topiramate 50 MG Oral Tablet	SCD	9

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TOPIRAMATE Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20180813

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-647-01	topiramate	100 in 1 BOTTLE	TABLET, FILM COATED	100	9
65841-647-05	topiramate	500 in 1 BOTTLE	TABLET, FILM COATED	500	9
65841-647-14	topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60	9
65841-647-16	topiramate	90 in 1 BOTTLE	TABLET, FILM COATED	90	9
65841-648-01	topiramate	100 in 1 BOTTLE	TABLET, FILM COATED	100	9
65841-648-05	topiramate	500 in 1 BOTTLE	TABLET, FILM COATED	500	9
65841-648-14	topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60	9
65841-648-16	topiramate	90 in 1 BOTTLE	TABLET, FILM COATED	90	9
65841-649-01	topiramate	100 in 1 BOTTLE	TABLET, FILM COATED	100	9
65841-649-05	topiramate	500 in 1 BOTTLE	TABLET, FILM COATED	500	9
65841-649-14	topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60	9
65841-649-16	topiramate	90 in 1 BOTTLE	TABLET, FILM COATED	90	9
65841-650-01	topiramate	100 in 1 BOTTLE	TABLET, FILM COATED	100	9
65841-650-05	topiramate	500 in 1 BOTTLE	TABLET, FILM COATED	500	9
65841-650-14	topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60	9
65841-650-16	topiramate	90 in 1 BOTTLE	TABLET, FILM COATED	90	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-647	TOPIRAMATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	9	Current NDC, Legacy NDC, 4 package rows	20240817_57016639-89fe-43ad-89c4-5e7a756dddec.zip
65841-648	TOPIRAMATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	9	Current NDC, Legacy NDC, 4 package rows	20240817_57016639-89fe-43ad-89c4-5e7a756dddec.zip
65841-649	TOPIRAMATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	9	Current NDC, Legacy NDC, 4 package rows	20240817_57016639-89fe-43ad-89c4-5e7a756dddec.zip
65841-650	TOPIRAMATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	9	Current NDC, Legacy NDC, 4 package rows	20240817_57016639-89fe-43ad-89c4-5e7a756dddec.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	1
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
LACTOSE, ANHYDROUS	INACTIVE INGREDIENT	3SY5LH9PMK	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

topiramate
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS LACTOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-647	65841-647-14, 65841-647-16, 65841-647-01, 65841-647-05
65841-648	65841-648-14, 65841-648-16, 65841-648-01, 65841-648-05
65841-649	65841-649-14, 65841-649-16, 65841-649-01, 65841-649-05
65841-650	65841-650-14, 65841-650-16, 65841-650-01, 65841-650-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOPIRAMATE	0H73WJJ391	ACTIB
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
TOPIRAMATE	0H73WJJ391	ACTIB
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
TOPIRAMATE	0H73WJJ391	ACTIB
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
TOPIRAMATE	0H73WJJ391	ACTIB
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 140 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
LACTOSE, ANHYDROUS	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL	2906 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
LACTOSE, ANHYDROUS	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL	2906 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
LACTOSE, ANHYDROUS	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL	2906 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
LACTOSE, ANHYDROUS	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL	2906 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
LACTOSE, ANHYDROUS	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL	2906 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
LACTOSE, ANHYDROUS	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL	2906 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
LACTOSE, ANHYDROUS	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL	2906 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
LACTOSE, ANHYDROUS	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL	2906 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 20 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078235-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078235-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078235-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078235-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078235-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078235-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078235-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-004	AB	1	`caaa826d4ba7…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	Zydus Lifesciences Limited	57016639-89fe-43ad-89c4-5e7a756dddec	2024-08-14		Exact identifier ndc (package): 65841-648-14 ndc (package): 65841-647-16 ndc (package): 65841-648-05 ndc (package): 65841-649-14 ndc (package): 65841-649-01 ndc (package): 65841-647-01 ndc (package): 65841-649-16 ndc (package): 65841-648-01 ndc (package): 65841-650-05 ndc (package): 65841-649-05 ndc (package): 65841-650-14 ndc (package): 65841-647-05 ndc (package): 65841-648-16 ndc (package): 65841-650-16 ndc (package): 65841-647-14 ndc (package): 65841-650-01 ndc (product): 65841-648 ndc (product): 65841-647 ndc (product): 65841-649 ndc (product): 65841-650 ndc11 (package): 65841064705 ndc11 (package): 65841065014 ndc11 (package): 65841064916 ndc11 (package): 65841064816 ndc11 (package): 65841065016 ndc11 (package): 65841065001 ndc11 (package): 65841064814 ndc11 (package): 65841064801 ndc11 (package): 65841064901 ndc11 (package): 65841064805 ndc11 (package): 65841064716 ndc11 (package): 65841064905 ndc11 (package): 65841064714 ndc11 (package): 65841065005 ndc11 (package): 65841064701 ndc11 (package): 65841064914 spl id: 85c62092-3b8c-43af-a980-e2d959e0c341 spl set id: 57016639-89fe-43ad-89c4-5e7a756dddec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.