topiramate

Product NDC: 68382-139
11-digit product format: 683820139
Labeler code: 68382
Product ID: 68382-139_48ba6ac8-7f36-4a5c-8055-295af6083862
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA078235
Marketing category: ANDA
Marketing start: 2009-03-27
Substance: TOPIRAMATE
Active strength: 50 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: 2027-12-31
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.

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: topiramate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOPIRAMATE	50 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
151226	Internal RxNorm lookup
199888	Internal RxNorm lookup
199889	Internal RxNorm lookup
199890	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
67dcdd6e-48bc-418e-a887-805929d83ce0	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68382-139-01	topiramate	100 in 1 BOTTLE	TABLET, FILM COATED	100	28
68382-139-05	topiramate	500 in 1 BOTTLE	TABLET, FILM COATED	500	28
68382-139-14	topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60	28
68382-139-16	topiramate	90 in 1 BOTTLE	TABLET, FILM COATED	90	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-139-05	EA - Each	68382-139	fbb3a5ad-4c8e-447a-8f15-57908b3d600f	1	2012-07-24
68382-139-14	EA - Each	68382-139	0455d17a-8b72-4d80-9ce3-e3690e806bb7	1	2012-07-24

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
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	11
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-139	TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	26	Current NDC, Legacy NDC, 4 package rows	20250419_67dcdd6e-48bc-418e-a887-805929d83ce0.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 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 ndc (product): 68382-139
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

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
151226	topiramate 50 MG Oral Tablet	PSN	ca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15	103
151226	topiramate 50 MG Oral Tablet	SCD	ca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15	103
199889	topiramate 100 MG Oral Tablet	PSN	67dcdd6e-48bc-418e-a887-805929d83ce0	28
199890	topiramate 200 MG Oral Tablet	PSN	67dcdd6e-48bc-418e-a887-805929d83ce0	28
199888	topiramate 25 MG Oral Tablet	PSN	67dcdd6e-48bc-418e-a887-805929d83ce0	28
151226	topiramate 50 MG Oral Tablet	PSN	67dcdd6e-48bc-418e-a887-805929d83ce0	28
199889	topiramate 100 MG Oral Tablet	SCD	67dcdd6e-48bc-418e-a887-805929d83ce0	28
199890	topiramate 200 MG Oral Tablet	SCD	67dcdd6e-48bc-418e-a887-805929d83ce0	28
199888	topiramate 25 MG Oral Tablet	SCD	67dcdd6e-48bc-418e-a887-805929d83ce0	28
151226	topiramate 50 MG Oral Tablet	SCD	67dcdd6e-48bc-418e-a887-805929d83ce0	28
151226	topiramate 50 MG Oral Tablet	PSN	6f461f84-bfad-44fa-a2bd-5ea1566444b5	21
151226	topiramate 50 MG Oral Tablet	SCD	6f461f84-bfad-44fa-a2bd-5ea1566444b5	21
199889	topiramate 100 MG Oral Tablet	PSN	1af94c80-2b17-409a-98f6-ce00f942351d	19
199890	topiramate 200 MG Oral Tablet	PSN	1af94c80-2b17-409a-98f6-ce00f942351d	19
199888	topiramate 25 MG Oral Tablet	PSN	1af94c80-2b17-409a-98f6-ce00f942351d	19
151226	topiramate 50 MG Oral Tablet	PSN	2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db	19
151226	topiramate 50 MG Oral Tablet	PSN	1af94c80-2b17-409a-98f6-ce00f942351d	19
199889	topiramate 100 MG Oral Tablet	SCD	1af94c80-2b17-409a-98f6-ce00f942351d	19
199890	topiramate 200 MG Oral Tablet	SCD	1af94c80-2b17-409a-98f6-ce00f942351d	19
199888	topiramate 25 MG Oral Tablet	SCD	1af94c80-2b17-409a-98f6-ce00f942351d	19
151226	topiramate 50 MG Oral Tablet	SCD	2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db	19
151226	topiramate 50 MG Oral Tablet	SCD	1af94c80-2b17-409a-98f6-ce00f942351d	19
151226	topiramate 50 MG Oral Tablet	PSN	83558f89-1adb-4d81-b19b-68721d48034b	7
151226	topiramate 50 MG Oral Tablet	SCD	83558f89-1adb-4d81-b19b-68721d48034b	7
151226	topiramate 50 MG Oral Tablet	PSN	b353e7fb-b976-96d8-e053-2995a90a110a	6
151226	topiramate 50 MG Oral Tablet	PSN	92637f92-9d7c-c246-e053-2995a90a0347	6
151226	topiramate 50 MG Oral Tablet	SCD	92637f92-9d7c-c246-e053-2995a90a0347	6
151226	topiramate 50 MG Oral Tablet	SCD	b353e7fb-b976-96d8-e053-2995a90a110a	6
151226	topiramate 50 MG Oral Tablet	PSN	033a2eb1-aba2-410b-8b9e-fafbc789ffa3	4
151226	topiramate 50 MG Oral Tablet	SCD	033a2eb1-aba2-410b-8b9e-fafbc789ffa3	4
151226	topiramate 50 MG Oral Tablet	PSN	813cc96c-5598-1ffd-e053-2991aa0ae9bd	3
151226	topiramate 50 MG Oral Tablet	PSN	f3321dc5-0fb7-0d12-e053-2a95a90a9694	3
151226	topiramate 50 MG Oral Tablet	SCD	813cc96c-5598-1ffd-e053-2991aa0ae9bd	3
151226	topiramate 50 MG Oral Tablet	SCD	f3321dc5-0fb7-0d12-e053-2a95a90a9694	3
151226	topiramate 50 MG Oral Tablet	PSN	9aefa085-6b91-445b-e053-2a95a90ae79f	1
151226	topiramate 50 MG Oral Tablet	PSN	acafcdc0-9374-778f-e053-2a95a90a4262	1
151226	topiramate 50 MG Oral Tablet	SCD	acafcdc0-9374-778f-e053-2a95a90a4262	1
151226	topiramate 50 MG Oral Tablet	SCD	9aefa085-6b91-445b-e053-2a95a90ae79f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-139-01	68382013901	100 TABLET, FILM COATED in 1 BOTTLE (68382-139-01)	2009-03-27	0000-00-00	No	No	Current
68382-139-05	68382013905	500 TABLET, FILM COATED in 1 BOTTLE (68382-139-05)	2009-03-27	0000-00-00	No	No	Current
68382-139-14	68382013914	60 TABLET, FILM COATED in 1 BOTTLE (68382-139-14)	2009-03-27	0000-00-00	No	No	Current
68382-139-16	68382013916	90 TABLET, FILM COATED in 1 BOTTLE (68382-139-16)	2009-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
topiramate	St. Mary's Medical Park Pharmacy	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	7
topiramate	Bryant Ranch Prepack	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	104
topiramate	AvPAK	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	2
topiramate	REMEDYREPACK INC.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	21
topiramate	REMEDYREPACK INC.	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	19
topiramate	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	28
topiramate	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Topiramate	American Health Packaging	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	19
topiramate	Preferred Pharmaceuticals Inc.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	7
Topiramate Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	6
topiramate	A-S Medication Solutions	2023-12-12	HUMAN PRESCRIPTION DRUG LABEL	14
topiramate	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	3
topiramate	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-03-03	HUMAN PRESCRIPTION DRUG LABEL	1
topiramate	medsource pharmaceuticals \| Zydus Pharmaceuticals (USA) Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	1
topiramate	Bryant Ranch Prepack	2019-08-07	HUMAN PRESCRIPTION DRUG LABEL	1
topiramate	Unit Dose Services	2017-11-07	HUMAN PRESCRIPTION DRUG LABEL	4
Topiramate	NCS HealthCare of KY, Inc dba Vangard Labs	2012-08-23	HUMAN PRESCRIPTION DRUG LABEL	14