Topiramate

Product NDC: 10370-368
11-digit product format: 103700368
Labeler code: 10370
Product ID: 10370-368_d2a47bf0-9716-4318-9f8c-bd3d43c0637f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Endo USA, Inc.
Application: ANDA205976
Marketing category: ANDA
Marketing start: 2023-03-24
Substance: TOPIRAMATE
Active strength: 200 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	10370-368	10370-368-05	D	Discontinued by firm		2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205976-001	TOPIRAMATE	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01
A205976-002	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04
A205976-003	TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04
A205976-004	TOPIRAMATE	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205976-001	AB1
A205976-002	AB1
A205976-003	AB1
A205976-004	AB1

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 3 · 93 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
2026-08-18 06:07:40	2026-07	A205976-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205976-002	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205976-003	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205976-004	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205976-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205976-002	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205976-003	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205976-004	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205976-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205976-002	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205976-003	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205976-004	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205976-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205976-002	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205976-003	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205976-004	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205976-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205976-002	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205976-003	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205976-004	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205976-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205976-002	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205976-003	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205976-004	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205976-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205976-002	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205976-003	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205976-004	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205976-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205976-002	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205976-003	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205976-004	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205976-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205976-002	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205976-003	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205976-004	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205976-001	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205976-002	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205976-003	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205976-004	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-05-04	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 93 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205976-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205976-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205976-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205976-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205976-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205976-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205976-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205976-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205976-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205976-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205976-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205976-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205976-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205976-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205976-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205976-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205976-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205976-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205976-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205976-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205976-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205976-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205976-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205976-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205976-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205976-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205976-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205976-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205976-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205976-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205976-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205976-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205976-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205976-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205976-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205976-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205976-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205976-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205976-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205976-004	AB1	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	200 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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9ac09563-5967-498c-93ae-675a7f4efc48	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	SPL version
10370-368-01	Topiramate	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	14
10370-368-05	Topiramate	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	14
10370-368-11	Topiramate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10370-368-01	EA - Each	10370-368	516e33c1-ad29-4803-9d61-21c81e115af8	1	2023-04-07
10370-368-11	EA - Each	10370-368	52b84ea9-9991-4572-a66a-ad44ee7ea4f4	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10370-368	TOPIRAMATE CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]	14	Current NDC, 3 package rows	20241212_9ac09563-5967-498c-93ae-675a7f4efc48.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Endo USA, Inc.	11e0924b-fbee-4ec4-b1e4-22d7683b21ee	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205976 application number: ANDA205976
Topiramate	TOPIRAMATE	Endo USA, Inc.	9ac09563-5967-498c-93ae-675a7f4efc48	2023-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205976 application number: ANDA205976 ndc (product): 10370-368

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
1437288	topiramate 200 MG 24HR Extended Release Oral Capsule	PSN	9ac09563-5967-498c-93ae-675a7f4efc48	14
1437288	24 HR topiramate 200 MG Extended Release Oral Capsule	SCD	9ac09563-5967-498c-93ae-675a7f4efc48	14
1437288	topiramate 200 MG 24 HR Extended Release Oral Capsule	SY	9ac09563-5967-498c-93ae-675a7f4efc48	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
10370-368-01	10370036801	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-01)	2023-03-24	No	No	Current
10370-368-05	10370036805	500 in 1 BOTTLE				Historical
10370-368-11	10370036811	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-368-11)	2023-03-24	No	No	Current