topiramate

Product NDC: 29300-117
11-digit product format: 293000117
Labeler code: 29300
Product ID: 29300-117_961973db-b7ab-40fa-ad75-4163738def9b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA090162
Marketing category: ANDA
Marketing start: 2013-07-01
Substance: TOPIRAMATE
Active strength: 100 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 1.

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
A090162-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A090162-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A090162-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A090162-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090162-001	AB
A090162-002	AB
A090162-003	AB
A090162-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090162-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090162-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090162-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: topiramate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOPIRAMATE	100 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
6ee00e82-799d-445e-b658-a9712c49a28e	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
29300-117-01	topiramate	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	20
29300-117-05	topiramate	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	20
29300-117-10	topiramate	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	20
29300-117-16	topiramate	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-117-05	EA - Each	29300-117	14061a9d-b868-4fc6-8213-e8a9b6f2d4d5	1	2016-02-04
29300-117-10	EA - Each	29300-117	27e54f2e-15ec-4418-a712-8cc5d5bde0ea	1	2015-08-04
29300-117-16	EA - Each	29300-117	431517b0-14d9-43c8-936b-19532b0349bc	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-117	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	19	Current NDC, Legacy NDC, 4 package rows	20250416_6ee00e82-799d-445e-b658-a9712c49a28e.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 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	St. Mary's Medical Park Pharmacy	46a305cb-ab73-0bca-e063-6294a90a9b85	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	12cd9be8-c5c2-4a16-9164-87963e22a88e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Coupler LLC	52ba9c4f-e7d0-4352-e063-6394a90af7e2	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Coupler LLC	50b10a3d-883c-8891-e063-6394a90a86a1	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Unichem Pharmaceuticals (USA), Inc.	6ee00e82-799d-445e-b658-a9712c49a28e	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162 ndc (product): 29300-117
topiramate	TOPIRAMATE	REMEDYREPACK INC.	be14624b-7eb9-4e7a-9274-1bb88270ecbe	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	4b1d3130-cf3c-d7da-e063-6294a90a6079	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	68b22d22-c2d3-4e90-b302-56f7cb731427	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	A-S Medication Solutions	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	A-S Medication Solutions	c6918801-f22c-4ba4-a396-da484d4334ca	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	49701840-5a32-4ac1-8b07-5c61decacb95	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	bf732c34-9078-496a-8093-f68594e76fcb	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	02cac021-e135-483f-bb5d-f3696eef0682	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	c320999e-b940-44d8-bf31-2fb78835ac2d	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	073d075d-d019-4834-b55d-9b9587914975	2025-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	30ca2fce-4e4c-439e-e063-6294a90af076	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	bbf0f882-1dcc-415d-82bb-acc64f4dc2bc	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	288d6b40-8c87-4f16-85a7-86166b5ac77f	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	2cf7ce9e-afc2-f94e-e063-6394a90a35d0	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	521be3f1-3ee7-45c7-9f0c-17e08b6c8fca	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162

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	02cac021-e135-483f-bb5d-f3696eef0682	101
199889	topiramate 100 MG Oral Tablet	SCD	02cac021-e135-483f-bb5d-f3696eef0682	101
199889	topiramate 100 MG Oral Tablet	PSN	12cd9be8-c5c2-4a16-9164-87963e22a88e	100
199889	topiramate 100 MG Oral Tablet	SCD	12cd9be8-c5c2-4a16-9164-87963e22a88e	100
199889	topiramate 100 MG Oral Tablet	PSN	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
199888	topiramate 25 MG Oral Tablet	PSN	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
151226	topiramate 50 MG Oral Tablet	PSN	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
199889	topiramate 100 MG Oral Tablet	SCD	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
199888	topiramate 25 MG Oral Tablet	SCD	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
151226	topiramate 50 MG Oral Tablet	SCD	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
199889	topiramate 100 MG Oral Tablet	PSN	6ee00e82-799d-445e-b658-a9712c49a28e	20
199890	topiramate 200 MG Oral Tablet	PSN	6ee00e82-799d-445e-b658-a9712c49a28e	20
199888	topiramate 25 MG Oral Tablet	PSN	6ee00e82-799d-445e-b658-a9712c49a28e	20
151226	topiramate 50 MG Oral Tablet	PSN	6ee00e82-799d-445e-b658-a9712c49a28e	20
199889	topiramate 100 MG Oral Tablet	SCD	6ee00e82-799d-445e-b658-a9712c49a28e	20
199890	topiramate 200 MG Oral Tablet	SCD	6ee00e82-799d-445e-b658-a9712c49a28e	20
199888	topiramate 25 MG Oral Tablet	SCD	6ee00e82-799d-445e-b658-a9712c49a28e	20
151226	topiramate 50 MG Oral Tablet	SCD	6ee00e82-799d-445e-b658-a9712c49a28e	20
199889	topiramate 100 MG Oral Tablet	PSN	584e16c5-5ffb-4bfc-ba80-4340afd25e8e	3
199889	topiramate 100 MG Oral Tablet	SCD	584e16c5-5ffb-4bfc-ba80-4340afd25e8e	3
199889	topiramate 100 MG Oral Tablet	PSN	2cf7ce9e-afc2-f94e-e063-6394a90a35d0	1
199889	topiramate 100 MG Oral Tablet	PSN	bbf0f882-1dcc-415d-82bb-acc64f4dc2bc	1
199889	topiramate 100 MG Oral Tablet	PSN	e4445eca-07a3-4aa0-bc3d-778401c864a0	1
199889	topiramate 100 MG Oral Tablet	SCD	2cf7ce9e-afc2-f94e-e063-6394a90a35d0	1
199889	topiramate 100 MG Oral Tablet	SCD	bbf0f882-1dcc-415d-82bb-acc64f4dc2bc	1
199889	topiramate 100 MG Oral Tablet	SCD	e4445eca-07a3-4aa0-bc3d-778401c864a0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-117-01	29300011701	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-117-01)	2013-07-01	0000-00-00	No	No	Current
29300-117-05	29300011705	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-117-05)	2013-07-01	0000-00-00	No	No	Current
29300-117-10	29300011710	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-117-10)	2013-07-01	0000-00-00	No	No	Current
29300-117-16	29300011716	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-117-16)	2013-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
topiramate	Bryant Ranch Prepack	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	101
topiramate	Unichem Pharmaceuticals (USA), Inc.	2026-04-06	HUMAN PRESCRIPTION DRUG LABEL	20
topiramate	A-S Medication Solutions	2025-11-10	HUMAN PRESCRIPTION DRUG LABEL	25
topiramate	Bryant Ranch Prepack	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	101
topiramate	Preferred Pharmaceuticals Inc.	2025-02-21	HUMAN PRESCRIPTION DRUG LABEL	1
topiramate	Advanced Rx of Tennessee, LLC	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	1
topiramate	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	2
topiramate	REMEDYREPACK INC.	2022-04-06	HUMAN PRESCRIPTION DRUG LABEL	4
topiramate	Proficient Rx LP	2020-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
topiramate	REMEDYREPACK INC.	2019-11-05	HUMAN PRESCRIPTION DRUG LABEL	3
topiramate	DOH CENTRAL PHARMACY	2019-01-29	HUMAN PRESCRIPTION DRUG LABEL	1