Topiramate

Product NDC: 68084-345
11-digit product format: 680840345
Labeler code: 68084
Product ID: 68084-345_40052c1b-5558-373b-e063-6394a90ad7d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA078235
Marketing category: ANDA
Marketing start: 2009-04-13
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: 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
A078235-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A078235-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A078235-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A078235-004	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
A078235-001	AB
A078235-002	AB
A078235-003	AB
A078235-004	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	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-004	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	A078235-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078235-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078235-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078235-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078235-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078235-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078235-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078235-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078235-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078235-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078235-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078235-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078235-004	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	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 · 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
1af94c80-2b17-409a-98f6-ce00f942351d	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-345-11	Topiramate	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		19
68084-345-21	Topiramate	30 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	30		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-345-11	EA - Each	68084-345	66dda1b9-7eea-4e06-bdad-7ecdfeb5368a	1	2012-07-24
68084-345-21	EA - Each	68084-345	89db12f3-011e-407a-bd85-a02efead4a29	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-345	TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	18	Current NDC, Legacy NDC, 2 package rows	20241109_1af94c80-2b17-409a-98f6-ce00f942351d.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 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	REMEDYREPACK INC.	7e0834ee-920b-496f-954d-f9d81c3ba2d6	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	0366164b-1846-443d-9564-dbe52d8d9b65	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	St. Mary's Medical Park Pharmacy	92637f92-9d7c-c246-e053-2995a90a0347	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	St. Mary's Medical Park Pharmacy	9221403c-467f-738e-e053-2995a90ac8fd	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	8abe45eb-cc75-4625-ae3d-5b2a038c4907	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	bffcd213-4f09-4a5b-8ccb-591a68be402b	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	57462baf-2f32-4bde-9627-2214c8af9370	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Bryant Ranch Prepack	ca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Coupler LLC	5461f33d-eaef-dce3-e063-6294a90aeff8	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	AvPAK	53c3f980-f05b-c671-e063-6294a90a77d5	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	6f461f84-bfad-44fa-a2bd-5ea1566444b5	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	b7539f52-06e9-4663-b401-92f5f83653cc	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	5ce65b7f-9215-47a8-a784-f87a810bd7e4	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	REMEDYREPACK INC.	149d20de-f262-4567-aa97-d4d28a1653cb	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Quallent Pharmaceuticals Health LLC	9dae6824-6913-42de-b98a-cdcb0d3b4a46	2026-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Zydus Pharmaceuticals USA Inc.	67dcdd6e-48bc-418e-a887-805929d83ce0	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Northwind Health Company, LLC	afd4c2b9-b80c-b43a-e053-2995a90ac923	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Northwind Health Company, LLC	f3321dc5-0fb7-0d12-e053-2a95a90a9694	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235
topiramate	TOPIRAMATE	Northwind Health Company, LLC	ffd7be08-050e-dfcb-e053-6394a90ad286	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078235 application number: ANDA078235

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	1af94c80-2b17-409a-98f6-ce00f942351d	19
199890	topiramate 200 MG Oral Tablet	PSN	1af94c80-2b17-409a-98f6-ce00f942351d	19
199888	topiramate 25 MG Oral Tablet	PSN	1af94c80-2b17-409a-98f6-ce00f942351d	19
151226	topiramate 50 MG Oral Tablet	PSN	1af94c80-2b17-409a-98f6-ce00f942351d	19
199889	topiramate 100 MG Oral Tablet	SCD	1af94c80-2b17-409a-98f6-ce00f942351d	19
199890	topiramate 200 MG Oral Tablet	SCD	1af94c80-2b17-409a-98f6-ce00f942351d	19
199888	topiramate 25 MG Oral Tablet	SCD	1af94c80-2b17-409a-98f6-ce00f942351d	19
151226	topiramate 50 MG Oral Tablet	SCD	1af94c80-2b17-409a-98f6-ce00f942351d	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-345-11	68084034511	1 in 1 BLISTER PACK						Historical
68084-345-21	68084034521	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-345-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-345-11)	30 blister pack	2009-04-13	0000-00-00	No	No	Current