topiramate

Product NDC: 29300-116
11-digit product format: 293000116
Labeler code: 29300
Product ID: 29300-116_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: 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 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090162-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090162-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090162-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090162-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 29300-116
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

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 · 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
29300-116-01	topiramate	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	20
29300-116-05	topiramate	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	20
29300-116-10	topiramate	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	20
29300-116-16	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
29300-116-05	EA - Each	29300-116	a40faabf-562e-4a54-b242-8cb613522b14	1	2016-02-04
29300-116-10	EA - Each	29300-116	98bd314e-5bad-4dcd-83e6-0eafb141b19a	1	2015-08-04
29300-116-16	EA - Each	29300-116	27dc2a38-520b-4647-a42f-d0e0d3538e8f	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
29300-116	TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	19	Current NDC, Legacy NDC, 4 package rows	20250416_6ee00e82-799d-445e-b658-a9712c49a28e.zip

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
151226	topiramate 50 MG Oral Tablet	PSN	bf732c34-9078-496a-8093-f68594e76fcb	101
151226	topiramate 50 MG Oral Tablet	SCD	bf732c34-9078-496a-8093-f68594e76fcb	101
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
199888	topiramate 25 MG Oral Tablet	PSN	f66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b	5
151226	topiramate 50 MG Oral Tablet	PSN	f66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b	5
151226	topiramate 50 MG Oral Tablet	PSN	073d075d-d019-4834-b55d-9b9587914975	5
199888	topiramate 25 MG Oral Tablet	SCD	f66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b	5
151226	topiramate 50 MG Oral Tablet	SCD	073d075d-d019-4834-b55d-9b9587914975	5
151226	topiramate 50 MG Oral Tablet	SCD	f66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b	5
151226	topiramate 50 MG Oral Tablet	PSN	816566bf-b909-606f-e053-2a91aa0ab8c9	4
151226	topiramate 50 MG Oral Tablet	PSN	f16065c0-9949-9ac4-e053-2995a90a3b02	4
151226	topiramate 50 MG Oral Tablet	SCD	816566bf-b909-606f-e053-2a91aa0ab8c9	4
151226	topiramate 50 MG Oral Tablet	SCD	f16065c0-9949-9ac4-e053-2995a90a3b02	4
151226	topiramate 50 MG Oral Tablet	PSN	cc918c0d-2b1e-4fa0-b4d3-9dbc28718018	3
151226	topiramate 50 MG Oral Tablet	SCD	cc918c0d-2b1e-4fa0-b4d3-9dbc28718018	3
151227	Topamax 50 MG Oral Tablet	PSN	33c0fc7a-aa48-34ae-e054-00144ff8d46c	1
151226	topiramate 50 MG Oral Tablet	PSN	33c0fc7a-aa48-34ae-e054-00144ff8d46c	1
151226	topiramate 50 MG Oral Tablet	PSN	30ca2fce-4e4c-439e-e063-6294a90af076	1
151226	topiramate 50 MG Oral Tablet	PSN	c6918801-f22c-4ba4-a396-da484d4334ca	1
151226	topiramate 50 MG Oral Tablet	PSN	288d6b40-8c87-4f16-85a7-86166b5ac77f	1
151226	topiramate 50 MG Oral Tablet	PSN	50b10a3d-883c-8891-e063-6394a90a86a1	1
151227	topiramate 50 MG Oral Tablet [Topamax]	SBD	33c0fc7a-aa48-34ae-e054-00144ff8d46c	1
151226	topiramate 50 MG Oral Tablet	SCD	30ca2fce-4e4c-439e-e063-6294a90af076	1
151226	topiramate 50 MG Oral Tablet	SCD	c6918801-f22c-4ba4-a396-da484d4334ca	1
151226	topiramate 50 MG Oral Tablet	SCD	33c0fc7a-aa48-34ae-e054-00144ff8d46c	1
151226	topiramate 50 MG Oral Tablet	SCD	288d6b40-8c87-4f16-85a7-86166b5ac77f	1
151226	topiramate 50 MG Oral Tablet	SCD	50b10a3d-883c-8891-e063-6394a90a86a1	1
151227	Topamax 50 MG Oral Tablet	SY	33c0fc7a-aa48-34ae-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-116-01	29300011601	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-116-01)	2013-07-01	0000-00-00	No	No	Current
29300-116-05	29300011605	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-116-05)	2013-07-01	0000-00-00	No	No	Current
29300-116-10	29300011610	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-116-10)	2013-07-01	0000-00-00	No	No	Current
29300-116-16	29300011616	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-116-16)	2013-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
topiramate	Coupler LLC	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	1
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	A-S Medication Solutions	2025-11-07	HUMAN PRESCRIPTION DRUG LABEL	1
topiramate	Bryant Ranch Prepack	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	101
topiramate	Bryant Ranch Prepack	2025-04-16	HUMAN PRESCRIPTION DRUG LABEL	5
topiramate	Advanced Rx of Tennessee, LLC	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
topiramate	Preferred Pharmaceuticals Inc.	2025-02-14	HUMAN PRESCRIPTION DRUG LABEL	1
Topiramate Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	4
topiramate	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	5
topiramate	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	4
topiramate	REMEDYREPACK INC.	2022-03-29	HUMAN PRESCRIPTION DRUG LABEL	5
topiramate	Proficient Rx LP	2020-02-01	HUMAN PRESCRIPTION DRUG LABEL	3
TOPIRAMATE	DIRECT RX	2016-05-26	HUMAN PRESCRIPTION DRUG LABEL	1