Topiramate

Product NDC: 71335-0337
Requested package NDC: 71335-0337-8
11-digit product format: 713350337
Labeler code: 71335
Product ID: 71335-0337_e3f4055d-0748-4d91-9e6f-aeae4548579b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076343
Marketing category: ANDA
Marketing start: 2014-06-12
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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0337	71335-0337-8	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 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
2026-09-14 22:38:34	2026-08	A076343-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076343-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076343-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076343-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2009-03-27	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076343-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076343-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076343-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076343-004	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199889	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
78ef4e4e-d391-4417-952b-06202d5000d8	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
71335-0337-1	Topiramate	60 in 1 BOTTLE	TABLET	60	102
71335-0337-2	Topiramate	30 in 1 BOTTLE	TABLET	30	102
71335-0337-3	Topiramate	90 in 1 BOTTLE	TABLET	90	102
71335-0337-4	Topiramate	120 in 1 BOTTLE	TABLET	120	102
71335-0337-5	Topiramate	50 in 1 BOTTLE	TABLET	50	102
71335-0337-6	Topiramate	14 in 1 BOTTLE	TABLET	14	102
71335-0337-7	Topiramate	45 in 1 BOTTLE	TABLET	45	102
71335-0337-8	Topiramate	7 in 1 BOTTLE	TABLET	7	102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0337-1	EA - Each	71335-0337	701dca53-0f29-4f6e-a34f-5bf9663ac869	1	2018-05-09
71335-0337-2	EA - Each	71335-0337	4828e1dc-33fd-468a-acf1-5d6a04184f30	1	2018-05-09
71335-0337-3	EA - Each	71335-0337	5be0d934-427c-4f62-ac78-8b72d8615aab	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0337	TOPIRAMATE TABLET [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 8 package rows	20240509_78ef4e4e-d391-4417-952b-06202d5000d8.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
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	78ef4e4e-d391-4417-952b-06202d5000d8	102
199889	topiramate 100 MG Oral Tablet	SCD	78ef4e4e-d391-4417-952b-06202d5000d8	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0337-8	71335033708	7 TABLET in 1 BOTTLE (71335-0337-8)	7 tablet	2022-02-09	0000-00-00	No	No	Current