Topiramate

Product NDC: 43063-734
11-digit product format: 430630734
Labeler code: 43063
Product ID: 43063-734_39f9738a-570e-d6a6-e063-6294a90ac1ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, 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 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
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.

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	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`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	A076343-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076343-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076343-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076343-004	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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 43063-734
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
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
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	e9cb3c29-098c-405f-a200-b436ac7fa1a2	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
151226	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
e39d2549-b489-426d-b576-741537e112e7	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
43063-734-07	Topiramate	7 in 1 BOTTLE, PLASTIC	TABLET	7	23
43063-734-21	Topiramate	21 in 1 BOTTLE, PLASTIC	TABLET	21	23
43063-734-30	Topiramate	30 in 1 BOTTLE, PLASTIC	TABLET	30	23
43063-734-60	Topiramate	60 in 1 BOTTLE, PLASTIC	TABLET	60	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-734-07	EA - Each	43063-734	ddeb7784-8be3-4127-9b50-a20e02108ca2	1	2018-04-19
43063-734-21	EA - Each	43063-734	58615c26-5b3f-4bdb-8bd8-1304230f668c	1	2017-03-06
43063-734-30	EA - Each	43063-734	4bafdae6-1ce8-4df8-bfcb-7301b037f83f	1	2017-03-06
43063-734-60	EA - Each	43063-734	94a1baa4-c137-437c-9eaa-c5c17e5b37b2	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-734	TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.]	22	Current NDC, Legacy NDC, 4 package rows	20250316_e39d2549-b489-426d-b576-741537e112e7.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	e39d2549-b489-426d-b576-741537e112e7	23
151226	topiramate 50 MG Oral Tablet	SCD	e39d2549-b489-426d-b576-741537e112e7	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-734-07	43063073407	7 TABLET in 1 BOTTLE, PLASTIC (43063-734-07)	7 tablet	2017-03-07	0000-00-00	No	No	Current
43063-734-21	43063073421	21 TABLET in 1 BOTTLE, PLASTIC (43063-734-21)	21 tablet	2017-01-31	0000-00-00	No	No	Current
43063-734-30	43063073430	30 TABLET in 1 BOTTLE, PLASTIC (43063-734-30)	30 tablet	2017-01-04	0000-00-00	No	No	Current
43063-734-60	43063073460	60 TABLET in 1 BOTTLE, PLASTIC (43063-734-60)	60 tablet	2016-12-28	0000-00-00	No	No	Current