Topiramate

Product NDC: 69097-123
11-digit product format: 690970123
Labeler code: 69097
Product ID: 69097-123_71f493d9-3aaa-4b13-8057-012e96e11dbc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA076343
Marketing category: ANDA
Marketing start: 2014-06-12
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: 2026-12-31
Current FDA listing: Yes

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
A076343-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A076343-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A076343-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A076343-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076343-001	AB
A076343-002	AB
A076343-003	AB
A076343-004	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 5 · 168 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	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A076343-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076343-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076343-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076343-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076343-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076343-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076343-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076343-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076343-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076343-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076343-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076343-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076343-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076343-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076343-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076343-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076343-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076343-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076343-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076343-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076343-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076343-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076343-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076343-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076343-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076343-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076343-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076343-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076343-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076343-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076343-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076343-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076343-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076343-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076343-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076343-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076343-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076343-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076343-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076343-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Topiramate
Listing expiration: 2026-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
151226	Internal RxNorm lookup
199888	Internal RxNorm lookup
199889	Internal RxNorm lookup
199890	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
ca4ec248-285d-4066-8f89-5ed0c538c4c9	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
69097-123-03	Topiramate	60 in 1 BOTTLE	TABLET	60	21
69097-123-12	Topiramate	500 in 1 BOTTLE	TABLET	500	21
69097-123-15	Topiramate	1000 in 1 BOTTLE	TABLET	1000	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-123-03	EA - Each	69097-123	bc91dd47-b1ca-4617-8767-c14f50a222a0	1	2015-02-02
69097-123-12	EA - Each	69097-123	394ec7e4-1429-4308-80ea-2767f7fa92fd	1	2015-02-02
69097-123-15	EA - Each	69097-123	5b442eb6-61f9-4a14-811b-8b8c37ed9fae	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET [CIPLA USA INC.]	5
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET [CIPLA USA INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET [CIPLA USA INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TOPIRAMATE TABLET [CIPLA USA INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TOPIRAMATE TABLET [CIPLA USA INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TOPIRAMATE TABLET [CIPLA USA INC.]	5
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	TOPIRAMATE TABLET [CIPLA USA INC.]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TOPIRAMATE TABLET [CIPLA USA INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPIRAMATE TABLET [CIPLA USA INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET [CIPLA USA INC.]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TOPIRAMATE TABLET [CIPLA USA INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPIRAMATE TABLET [CIPLA USA INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET [CIPLA USA INC.]	5
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET [CIPLA USA INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET [CIPLA USA INC.]	5
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET, FILM COATED [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-123	TOPIRAMATE TABLET [CIPLA USA INC.]	19	Current NDC, Legacy NDC, 3 package rows	20230608_ca4ec248-285d-4066-8f89-5ed0c538c4c9.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	c90d81a9-a87b-48b0-8cf1-172b82e30127	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	44095c2b-2e90-45d2-ab45-d0961c41550d	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	b71c09c5-43dd-4d98-9ab6-0b0c99908cac	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	f8aaf403-0e15-4bbb-b88b-253d93439688	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Coupler LLC	55f2aca4-b961-a746-e063-6294a90ae8ce	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	REMEDYREPACK INC.	0cf388dc-d8f1-4478-bf5f-e64638ee5801	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	C	164cb1f7-1a41-675f-e063-6294a90ae0dd	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	A-S Medication Solutions	7f1e4475-6326-47a3-a317-b04b74b7c109	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	A-S Medication Solutions	55e71f43-1cd5-4efc-9641-fda0a09c30f0	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Northwind Health Company, LLC	ca45d478-7214-5bc7-e053-2995a90aa601	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	1f327383-beb3-4d15-add6-5f1c749f2b3f	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals, Inc.	490f109f-30cb-0790-e054-00144ff88e88	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	9e516204-8f39-43c9-9f7e-d9777586f321	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	PD-Rx Pharmaceuticals, Inc.	e39d2549-b489-426d-b576-741537e112e7	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	A-S Medication Solutions	f16b14a2-297f-4adb-8d7a-5f43785faef7	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	A-S Medication Solutions	ea0bcab1-cfe1-491c-875e-8c865449557e	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Cipla USA Inc.	ca4ec248-285d-4066-8f89-5ed0c538c4c9	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343 ndc (product): 69097-123
Topiramate	TOPIRAMATE	Proficient Rx LP	d63b64dd-b420-4283-9bac-92ba43c9f429	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	eca774cf-2e4e-7642-e053-2a95a90a847d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	d8dff98f-185e-77ba-e053-2995a90aed2f	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343

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
199889	topiramate 100 MG Oral Tablet	PSN	f16b14a2-297f-4adb-8d7a-5f43785faef7	26
151226	topiramate 50 MG Oral Tablet	PSN	f16b14a2-297f-4adb-8d7a-5f43785faef7	26
199889	topiramate 100 MG Oral Tablet	SCD	f16b14a2-297f-4adb-8d7a-5f43785faef7	26
151226	topiramate 50 MG Oral Tablet	SCD	f16b14a2-297f-4adb-8d7a-5f43785faef7	26
151226	topiramate 50 MG Oral Tablet	PSN	e39d2549-b489-426d-b576-741537e112e7	23
151226	topiramate 50 MG Oral Tablet	SCD	e39d2549-b489-426d-b576-741537e112e7	23
199889	topiramate 100 MG Oral Tablet	PSN	ca4ec248-285d-4066-8f89-5ed0c538c4c9	21
199890	topiramate 200 MG Oral Tablet	PSN	ca4ec248-285d-4066-8f89-5ed0c538c4c9	21
199888	topiramate 25 MG Oral Tablet	PSN	ca4ec248-285d-4066-8f89-5ed0c538c4c9	21
151226	topiramate 50 MG Oral Tablet	PSN	ca4ec248-285d-4066-8f89-5ed0c538c4c9	21
199889	topiramate 100 MG Oral Tablet	SCD	ca4ec248-285d-4066-8f89-5ed0c538c4c9	21
199890	topiramate 200 MG Oral Tablet	SCD	ca4ec248-285d-4066-8f89-5ed0c538c4c9	21
199888	topiramate 25 MG Oral Tablet	SCD	ca4ec248-285d-4066-8f89-5ed0c538c4c9	21
151226	topiramate 50 MG Oral Tablet	SCD	ca4ec248-285d-4066-8f89-5ed0c538c4c9	21
199890	topiramate 200 MG Oral Tablet	PSN	2082548c-371c-4c98-98a6-effe0a9bd2a4	6
151226	topiramate 50 MG Oral Tablet	PSN	2082548c-371c-4c98-98a6-effe0a9bd2a4	6
199890	topiramate 200 MG Oral Tablet	SCD	2082548c-371c-4c98-98a6-effe0a9bd2a4	6
151226	topiramate 50 MG Oral Tablet	SCD	2082548c-371c-4c98-98a6-effe0a9bd2a4	6
151226	topiramate 50 MG Oral Tablet	PSN	d8dff98f-185e-77ba-e053-2995a90aed2f	5
151226	topiramate 50 MG Oral Tablet	SCD	d8dff98f-185e-77ba-e053-2995a90aed2f	5
199888	topiramate 25 MG Oral Tablet	PSN	8a35067c-2f44-52b3-e053-2995a90a6bc1	4
151226	topiramate 50 MG Oral Tablet	PSN	8a35067c-2f44-52b3-e053-2995a90a6bc1	4
151226	topiramate 50 MG Oral Tablet	PSN	ca45d478-7214-5bc7-e053-2995a90aa601	4
199888	topiramate 25 MG Oral Tablet	SCD	8a35067c-2f44-52b3-e053-2995a90a6bc1	4
151226	topiramate 50 MG Oral Tablet	SCD	8a35067c-2f44-52b3-e053-2995a90a6bc1	4
151226	topiramate 50 MG Oral Tablet	SCD	ca45d478-7214-5bc7-e053-2995a90aa601	4
151226	topiramate 50 MG Oral Tablet	PSN	70a7a4bf-2f02-6deb-e053-2991aa0ae87f	3
151226	topiramate 50 MG Oral Tablet	PSN	ea0bcab1-cfe1-491c-875e-8c865449557e	3
151226	topiramate 50 MG Oral Tablet	PSN	57ac12ed-27f0-4f5c-96ae-a7433714b429	3
151226	topiramate 50 MG Oral Tablet	SCD	70a7a4bf-2f02-6deb-e053-2991aa0ae87f	3
151226	topiramate 50 MG Oral Tablet	SCD	57ac12ed-27f0-4f5c-96ae-a7433714b429	3
151226	topiramate 50 MG Oral Tablet	SCD	ea0bcab1-cfe1-491c-875e-8c865449557e	3
151226	topiramate 50 MG Oral Tablet	PSN	972c91c2-cfb4-e61d-e053-2a95a90a1b66	2
151226	topiramate 50 MG Oral Tablet	PSN	a578340b-0032-4cab-a57a-e1959829e6eb	2
151226	topiramate 50 MG Oral Tablet	SCD	972c91c2-cfb4-e61d-e053-2a95a90a1b66	2
151226	topiramate 50 MG Oral Tablet	SCD	a578340b-0032-4cab-a57a-e1959829e6eb	2
199889	topiramate 100 MG Oral Tablet	PSN	4e476c33-3590-4c6f-981d-915623cdacf0	1
199890	topiramate 200 MG Oral Tablet	PSN	4e476c33-3590-4c6f-981d-915623cdacf0	1
199888	topiramate 25 MG Oral Tablet	PSN	4e476c33-3590-4c6f-981d-915623cdacf0	1
151226	topiramate 50 MG Oral Tablet	PSN	4e476c33-3590-4c6f-981d-915623cdacf0	1
151226	topiramate 50 MG Oral Tablet	PSN	299cf1b6-67ca-46ad-913d-5f474ae7b8a0	1
151226	topiramate 50 MG Oral Tablet	PSN	71c6e31c-13dc-7f9c-e053-2a95a90ae742	1
199889	topiramate 100 MG Oral Tablet	SCD	4e476c33-3590-4c6f-981d-915623cdacf0	1
199890	topiramate 200 MG Oral Tablet	SCD	4e476c33-3590-4c6f-981d-915623cdacf0	1
199888	topiramate 25 MG Oral Tablet	SCD	4e476c33-3590-4c6f-981d-915623cdacf0	1
151226	topiramate 50 MG Oral Tablet	SCD	4e476c33-3590-4c6f-981d-915623cdacf0	1
151226	topiramate 50 MG Oral Tablet	SCD	71c6e31c-13dc-7f9c-e053-2a95a90ae742	1
151226	topiramate 50 MG Oral Tablet	SCD	299cf1b6-67ca-46ad-913d-5f474ae7b8a0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-123-03	69097012303	60 TABLET in 1 BOTTLE (69097-123-03)	60 tablet	2014-06-12	0000-00-00	No	No	Current
69097-123-12	69097012312	500 TABLET in 1 BOTTLE (69097-123-12)	500 tablet	2014-06-12	0000-00-00	No	No	Current
69097-123-15	69097012315	1000 TABLET in 1 BOTTLE (69097-123-15)	1000 tablet	2014-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topiramate	REMEDYREPACK INC.	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	8
Topiramate	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Topiramate	PD-Rx Pharmaceuticals, Inc.	2025-07-15	HUMAN PRESCRIPTION DRUG LABEL	23
Topiramate	A-S Medication Solutions	2025-06-09	HUMAN PRESCRIPTION DRUG LABEL	26
Topiramate	A-S Medication Solutions	2025-04-29	HUMAN PRESCRIPTION DRUG LABEL	3
Topiramate	Cipla USA Inc. \| CIPLA LIMITED KURKUMBH \| CIPLA LIMITED VIRGONAGAR	2025-04-09	HUMAN PRESCRIPTION DRUG LABEL	21
Topiramate Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	5
Topiramate	NuCare Pharmaceuticals, Inc.	2024-03-01	HUMAN PRESCRIPTION DRUG LABEL	4
TOPIRAMATE	DirectRX	2023-05-23	HUMAN PRESCRIPTION DRUG LABEL	6
TOPIRAMATE	Direct_Rx	2023-03-15	HUMAN PRESCRIPTION DRUG LABEL	4
Topiramate	RPK Pharmaceuticals, Inc.	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
Topiramate	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-09-09	HUMAN PRESCRIPTION DRUG LABEL	1
Topiramate	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	3
Topiramate	Bryant Ranch Prepack	2022-02-09	HUMAN PRESCRIPTION DRUG LABEL	100
Topiramate	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	2
Topiramate	Lake Erie Medical DBA Quality Care Products LLC	2021-02-18	HUMAN PRESCRIPTION DRUG LABEL	11
Topiramate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-25	HUMAN PRESCRIPTION DRUG LABEL	3
Topiramate	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-09-10	HUMAN PRESCRIPTION DRUG LABEL	2
Topiramate	REMEDYREPACK INC.	2020-03-31	HUMAN PRESCRIPTION DRUG LABEL	6
Topiramate	St. Mary's Medical Park Pharmacy \| Cipla Limited, Bangalore \| Cipla Kurkumbh	2018-11-21	HUMAN PRESCRIPTION DRUG LABEL	3
Topiramate	Medsource Pharmaceuticals \| Medsorce Pharmaceuticals	2018-07-24	HUMAN PRESCRIPTION DRUG LABEL	1
Topiramate	Preferred Pharmaceuticals Inc.	2017-08-28	HUMAN PRESCRIPTION DRUG LABEL	1
Topiramate	Aidarex Pharmaceuticals LLC	2017-05-25	HUMAN PRESCRIPTION DRUG LABEL	1