TOPIRAMATE

Product NDC: 68462-371
11-digit product format: 684620371
Labeler code: 68462
Product ID: 68462-371_4a2276a1-54f6-4de6-8710-c2c088a23e76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA210278
Marketing category: ANDA
Marketing start: 2021-02-01
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210278-001	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01
A210278-002	TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01
A210278-003	TOPIRAMATE	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01
A210278-004	TOPIRAMATE	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01
A210278-005	TOPIRAMATE	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210278-001	AB2
A210278-002	AB2
A210278-003	AB2
A210278-004	AB2
A210278-005	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 5 · 185 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
2026-09-14 22:38:34	2026-08	A210278-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210278-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210278-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210278-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210278-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210278-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210278-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210278-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210278-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210278-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210278-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210278-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210278-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210278-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210278-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210278-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210278-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210278-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210278-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210278-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210278-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210278-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210278-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210278-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210278-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210278-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210278-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210278-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210278-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210278-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210278-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210278-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210278-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210278-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210278-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210278-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210278-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210278-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210278-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210278-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2021-02-01	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 185 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210278-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210278-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210278-003	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210278-004	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210278-005	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210278-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210278-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210278-003	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210278-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210278-005	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210278-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210278-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210278-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210278-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210278-005	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210278-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210278-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210278-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210278-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210278-005	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210278-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210278-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210278-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210278-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210278-005	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210278-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210278-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210278-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210278-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210278-005	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210278-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210278-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210278-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210278-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210278-005	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210278-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210278-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210278-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210278-004	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210278-005	AB2	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

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

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 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
54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	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
68462-371-05	TOPIRAMATE	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	10
68462-371-30	TOPIRAMATE	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	10
68462-371-90	TOPIRAMATE	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-371-30	EA - Each	68462-371	3cbc8238-c843-4303-9e36-ab7d6bf2e148	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-371	TOPIRAMATE CAPSULE, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	8	Current NDC, Legacy NDC, 3 package rows	20250524_54bfabce-1f8a-40ee-8b55-efce8fe6fbf1.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	Glenmark Pharmaceuticals Inc., USA	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210278 application number: ANDA210278 ndc (product): 68462-371

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	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1494769	topiramate 150 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812419	topiramate 200 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812421	topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812425	topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812427	Sprinkle 24 HR topiramate 100 MG Extended Release Oral Capsule	SCD	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1494769	Sprinkle 24 HR topiramate 150 MG Extended Release Oral Capsule	SCD	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812419	Sprinkle 24 HR topiramate 200 MG Extended Release Oral Capsule	SCD	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812421	Sprinkle 24 HR topiramate 25 MG Extended Release Oral Capsule	SCD	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812425	Sprinkle 24 HR topiramate 50 MG Extended Release Oral Capsule	SCD	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812427	topiramate 100 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1494769	topiramate 150 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812419	topiramate 200 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812421	topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule	SY	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10
1812425	topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule	SY	54bfabce-1f8a-40ee-8b55-efce8fe6fbf1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-371-05	68462037105	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-371-05)	2021-02-01	0000-00-00	No	No	Current
68462-371-30	68462037130	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-371-30)	2021-02-01	0000-00-00	No	No	Current
68462-371-90	68462037190	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-371-90)	2021-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOPIRAMATE	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	10