Topiramate

Product NDC: 69680-178
11-digit product format: 696800178
Labeler code: 69680
Product ID: 69680-178_0a7f1a1b-961e-4458-8312-7920a78e4dbe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Vitruvias Therapeutics, Inc.
Application: ANDA215638
Marketing category: ANDA
Marketing start: 2025-04-07
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215638-001	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05
A215638-002	TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05
A215638-003	TOPIRAMATE	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05
A215638-004	TOPIRAMATE	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05
A215638-005	TOPIRAMATE	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A215638-001	AB2
A215638-002	AB2
A215638-003	AB2
A215638-004	AB2
A215638-005	AB2

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 2 · 45 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	A215638-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215638-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215638-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215638-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215638-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215638-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215638-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215638-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215638-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215638-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215638-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215638-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215638-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215638-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215638-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215638-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215638-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215638-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215638-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215638-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215638-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215638-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215638-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215638-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215638-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215638-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215638-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215638-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215638-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215638-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215638-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215638-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215638-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215638-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215638-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215638-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215638-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215638-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215638-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215638-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2024-11-05	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 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	A215638-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215638-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215638-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215638-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215638-005	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215638-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215638-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215638-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215638-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215638-005	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215638-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215638-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215638-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215638-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215638-005	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215638-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215638-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215638-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215638-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215638-005	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215638-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215638-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215638-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215638-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215638-005	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215638-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215638-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215638-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215638-004	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215638-005	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215638-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215638-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215638-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215638-004	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215638-005	AB2	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215638-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215638-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215638-003	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215638-004	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215638-005	AB2	1	`d8e5a09893c0…`

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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1494769	Internal RxNorm lookup
1812419	Internal RxNorm lookup
1812421	Internal RxNorm lookup
1812425	Internal RxNorm lookup
1812427	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
a9d7c5ef-daf9-4f97-8673-7f4a2007f408	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69680-178-30	Topiramate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69680-178-30	EA - Each	69680-178	a312bd6e-b9f3-42f6-847a-f6efb28dd1bb	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69680-178	TOPIRAMATE CAPSULE, EXTENDED RELEASE [VITRUVIAS THERAPEUTICS, INC.]	1	Current NDC, 1 package rows	20250408_a9d7c5ef-daf9-4f97-8673-7f4a2007f408.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Vitruvias Therapeutics, Inc.	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215638 application number: ANDA215638 ndc (product): 69680-178

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
1812427	topiramate 100 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1494769	topiramate 150 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812419	topiramate 200 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812421	topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812425	topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812427	Sprinkle 24 HR topiramate 100 MG Extended Release Oral Capsule	SCD	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1494769	Sprinkle 24 HR topiramate 150 MG Extended Release Oral Capsule	SCD	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812419	Sprinkle 24 HR topiramate 200 MG Extended Release Oral Capsule	SCD	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812421	Sprinkle 24 HR topiramate 25 MG Extended Release Oral Capsule	SCD	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812425	Sprinkle 24 HR topiramate 50 MG Extended Release Oral Capsule	SCD	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812427	topiramate 100 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1494769	topiramate 150 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812419	topiramate 200 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812421	topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule	SY	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2
1812425	topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule	SY	a9d7c5ef-daf9-4f97-8673-7f4a2007f408	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69680-178-30	69680017830	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-178-30)	2025-04-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topiramate	Vitruvias Therapeutics, Inc. \| Xiamen LP Pharmaceutical Co., Ltd.	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	2