Topiramate

Product NDC: 70710-1040
Requested package NDC: 70710-1040-9
11-digit product format: 707101040
Labeler code: 70710
Product ID: 70710-1040_bb736981-167f-4de6-a285-0e840ae37fc7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA208949
Marketing category: ANDA
Marketing start: 2023-01-17
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 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
A208949-001	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29
A208949-002	TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29
A208949-003	TOPIRAMATE	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29
A208949-004	TOPIRAMATE	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29
A208949-005	TOPIRAMATE	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208949-001	AB2
A208949-002	AB2
A208949-003	AB2
A208949-004	AB2
A208949-005	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 4 · 130 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	A208949-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208949-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208949-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208949-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208949-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208949-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208949-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208949-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208949-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208949-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208949-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208949-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208949-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208949-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208949-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208949-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208949-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208949-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208949-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208949-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208949-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208949-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208949-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208949-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208949-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208949-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208949-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208949-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208949-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208949-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208949-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208949-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208949-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208949-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208949-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208949-001	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208949-002	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208949-003	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208949-004	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208949-005	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	2022-11-29	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 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	A208949-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208949-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208949-003	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208949-004	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208949-005	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208949-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208949-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208949-003	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208949-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208949-005	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208949-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208949-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208949-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208949-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208949-005	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208949-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208949-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208949-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208949-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208949-005	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208949-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208949-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208949-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208949-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208949-005	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208949-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208949-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208949-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208949-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208949-005	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208949-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208949-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208949-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208949-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208949-005	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208949-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208949-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208949-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208949-004	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208949-005	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	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
a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70710-1040-3	Topiramate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		7
70710-1040-9	Topiramate	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70710-1040-3	EA - Each	70710-1040	f5884a14-1e04-492e-b045-54833187af24	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1040	TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	6	Current NDC, 2 package rows	20250411_a5ca2fce-bd2d-40db-b963-e3ec27c8bf23.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	Zydus Pharmaceuticals USA Inc.	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208949 application number: ANDA208949 ndc (package): 70710-1040-9 ndc (product): 70710-1040 ndc11 (package): 70710104009
Topiramate	TOPIRAMATE	Zydus Lifesciences Limited	57b5d67b-b29b-4c18-a53d-51d5374f3be3	2023-09-28		Exact identifier application applno (ANDA): 208949 application number: ANDA208949

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	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1494769	topiramate 150 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812419	topiramate 200 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812421	topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812425	topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule	PSN	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812427	Sprinkle 24 HR topiramate 100 MG Extended Release Oral Capsule	SCD	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1494769	Sprinkle 24 HR topiramate 150 MG Extended Release Oral Capsule	SCD	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812419	Sprinkle 24 HR topiramate 200 MG Extended Release Oral Capsule	SCD	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812421	Sprinkle 24 HR topiramate 25 MG Extended Release Oral Capsule	SCD	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812425	Sprinkle 24 HR topiramate 50 MG Extended Release Oral Capsule	SCD	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812427	topiramate 100 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1494769	topiramate 150 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812419	topiramate 200 MG Sprinkle 24 HR Extended Release Oral Capsule	SY	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812421	topiramate 25 MG Sprinkle 24HR Extended Release Oral Capsule	SY	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7
1812425	topiramate 50 MG Sprinkle 24HR Extended Release Oral Capsule	SY	a5ca2fce-bd2d-40db-b963-e3ec27c8bf23	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70710-1040-9	70710104009	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1040-9)	2023-01-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topiramate	Zydus Pharmaceuticals USA Inc. \| Zydus Worldwide DMCC \| Zydus Lifesciences Limited	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	7