topiramate

Product NDC: 65841-652
Requested package NDC: 65841-652-01
11-digit product format: 658410652
Labeler code: 65841
Product ID: 65841-652_c45924d5-c45b-4f31-afa5-0cbc090d2816
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA078877
Marketing category: ANDA
Marketing start: 2009-10-14
Substance: TOPIRAMATE
Active strength: 25 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 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078877-001	TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14
A078877-002	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14
A078877-003	TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078877-001	AB
A078877-002	AB
A078877-003	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 3 · 100 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
2026-10-15 13:18:30	2026-09	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2024-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL		2024-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL		2024-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL		2024-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL		2024-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078877-003	TOPIRAMATE	50MG	CAPSULE / ORAL		2024-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078877-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2009-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078877-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2009-10-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 95 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078877-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078877-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078877-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078877-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078877-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078877-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078877-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078877-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078877-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078877-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078877-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078877-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078877-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078877-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078877-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078877-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078877-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078877-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078877-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078877-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078877-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078877-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078877-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078877-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078877-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078877-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078877-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078877-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078877-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078877-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078877-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A078877-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078877-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078877-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078877-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078877-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078877-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078877-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078877-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078877-002	AB	1	`3f0d92c62455…`

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	25 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205315	Internal RxNorm lookup
205316	Internal RxNorm lookup
252413	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
6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	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
65841-652-01	topiramate	100 in 1 BOTTLE	CAPSULE, COATED PELLETS	100	11
65841-652-05	topiramate	500 in 1 BOTTLE	CAPSULE, COATED PELLETS	500	11
65841-652-10	topiramate	1000 in 1 BOTTLE	CAPSULE, COATED PELLETS	1000	11
65841-652-14	topiramate	60 in 1 BOTTLE	CAPSULE, COATED PELLETS	60	11
65841-652-16	topiramate	90 in 1 BOTTLE	CAPSULE, COATED PELLETS	90	11
65841-652-17	topiramate	28 in 1 BOTTLE	CAPSULE, COATED PELLETS	28	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED]	3
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED]	3
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	TOPIRAMATE CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TOPIRAMATE CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPIRAMATE CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TOPIRAMATE CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TOPIRAMATE CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	TOPIRAMATE CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE CAPSULE, COATED PELLETS [CADILA HEALTHCARE LIMITED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-652	TOPIRAMATE CAPSULE, COATED PELLETS [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 6 package rows	20241027_6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	REMEDYREPACK INC.	0c0a6774-e234-47a5-866e-462cfd99744c	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078877 application number: ANDA078877
topiramate	TOPIRAMATE	Zydus Pharmaceuticals USA Inc.	e4886adf-199d-4b19-a4ef-75f8f94cb54e	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078877 application number: ANDA078877
topiramate	TOPIRAMATE	Zydus Lifesciences Limited	6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	2024-10-25		Exact identifier application applno (ANDA): 078877 application number: ANDA078877 ndc (package): 65841-652-01 ndc (product): 65841-652 ndc11 (package): 65841065201

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
205316	topiramate 15 MG Oral Capsule	PSN	6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	11
205315	topiramate 25 MG Oral Capsule	PSN	6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	11
252413	topiramate 50 MG Oral Capsule	PSN	6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	11
205316	topiramate 15 MG Oral Capsule	SCD	6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	11
205315	topiramate 25 MG Oral Capsule	SCD	6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	11
252413	topiramate 50 MG Oral Capsule	SCD	6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-652-01	65841065201	100 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-01)	2009-10-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOPIRAMATE TABLETS and TOPIRAMATE CAPSULES	Zydus Lifesciences Limited	2024-10-25	HUMAN PRESCRIPTION DRUG LABEL	11