Topiramate

Product NDC: 72888-230
Requested package NDC: 72888-230-60
11-digit product format: 728880230
Labeler code: 72888
Product ID: 72888-230_4e8dd02d-2263-78d0-e063-6294a90a5f0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: CAPSULE
Route: ORAL
Labeler: Advagen Pharma Ltd
Application: ANDA216683
Marketing category: ANDA
Marketing start: 2025-05-27
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A216683-001	TOPIRAMATE	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2025-05-27
A216683-002	TOPIRAMATE	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2025-05-27
A216683-003	TOPIRAMATE	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2025-05-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216683-001	AB
A216683-002	AB
A216683-003	AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A216683-003	CGT	2026-02-01

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.

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	A216683-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2025-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216683-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2025-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216683-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2025-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216683-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2025-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216683-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2025-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216683-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2025-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216683-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2025-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216683-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2025-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216683-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2025-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216683-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2025-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216683-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2025-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216683-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2025-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216683-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2025-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216683-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2025-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216683-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2025-05-27	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216683-001	TOPIRAMATE	15MG	CAPSULE / ORAL	AB	2025-05-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216683-002	TOPIRAMATE	25MG	CAPSULE / ORAL	AB	2025-05-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216683-003	TOPIRAMATE	50MG	CAPSULE / ORAL	AB	2025-05-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216683-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216683-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216683-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216683-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216683-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216683-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216683-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216683-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216683-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216683-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216683-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216683-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216683-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216683-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216683-003	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216683-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216683-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216683-003	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	A216683-003	CGT	2026-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216683-003	CGT	2026-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216683-003	CGT	2026-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216683-003	CGT	2026-02-01	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216683-003	CGT	2026-02-01	`a50c72e98297…`

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 · 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
48169bbc-4fb2-4bc4-9bdd-de71bf7722df	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
72888-230-05	Topiramate	500 in 1 BOTTLE	CAPSULE	500	7
72888-230-12	Topiramate	120 in 1 BOTTLE	CAPSULE	120	7
72888-230-30	Topiramate	30 in 1 BOTTLE	CAPSULE	30	7
72888-230-60	Topiramate	60 in 1 BOTTLE	CAPSULE	60	7
72888-230-67	Topiramate	240 in 1 BOTTLE	CAPSULE	240	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72888-230-30	EA - Each	72888-230	878b769d-8dce-45dc-bb4d-50701d405869	1	2025-08-11

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	Advagen Pharma Ltd	48169bbc-4fb2-4bc4-9bdd-de71bf7722df	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216683 application number: ANDA216683 ndc (package): 72888-230-60 ndc (product): 72888-230 ndc11 (package): 72888023060

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	48169bbc-4fb2-4bc4-9bdd-de71bf7722df	7
205315	topiramate 25 MG Oral Capsule	PSN	48169bbc-4fb2-4bc4-9bdd-de71bf7722df	7
252413	topiramate 50 MG Oral Capsule	PSN	48169bbc-4fb2-4bc4-9bdd-de71bf7722df	7
205316	topiramate 15 MG Oral Capsule	SCD	48169bbc-4fb2-4bc4-9bdd-de71bf7722df	7
205315	topiramate 25 MG Oral Capsule	SCD	48169bbc-4fb2-4bc4-9bdd-de71bf7722df	7
252413	topiramate 50 MG Oral Capsule	SCD	48169bbc-4fb2-4bc4-9bdd-de71bf7722df	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72888-230-60	72888023060	60 CAPSULE in 1 BOTTLE (72888-230-60)	60 capsule	2025-05-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topiramate	Advagen Pharma Ltd \| Rubicon Research Limited	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	7