Topiramate

Product NDC: 68071-1971
11-digit product format: 680711971
Labeler code: 68071
Product ID: 68071-1971_3ab5a044-1530-14af-e063-6394a90a35ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA076343
Marketing category: ANDA
Marketing start: 2014-06-12
Substance: TOPIRAMATE
Active strength: 25 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

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1971-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1971-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1971-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1971-9	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1971-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-1971-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1971-9	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1971-6	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-1971-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1971-9	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1971-6	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-1971-3	`1332a3947898…`	`d4bfe170f9cd…`

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	25 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
199888	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
490f109f-30cb-0790-e054-00144ff88e88	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-1971-3	2024-07-16	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-6	2024-07-16	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-9	2024-07-16	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-3	2023-01-30	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-6	2023-01-30	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-9	2023-01-30	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-3	2021-02-23	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-6	2021-02-23	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-9	2021-02-23	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-3	2021-01-29	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-6	2021-01-29	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996
68071-1971-9	2021-01-29	These highlights do not include all the information needed to use TOPIRAMATE tablets, USP safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets USP, for oral Use. Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-1971-3	Topiramate	30 in 1 BOTTLE	TABLET	30	6
68071-1971-6	Topiramate	60 in 1 BOTTLE	TABLET	60	6
68071-1971-9	Topiramate	90 in 1 BOTTLE	TABLET	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1971	TOPIRAMATE TABLET [NUCARE PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 3 package rows	20240717_490f109f-30cb-0790-e054-00144ff88e88.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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals, Inc.	4a656a9f-8eb8-69b7-e054-00144ff8d46c	2024-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	78ef4e4e-d391-4417-952b-06202d5000d8	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	10a9e6fa-4d55-6b5c-e063-6294a90a608c	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	A-S Medication Solutions	93da6674-14dc-4c8d-9424-03e4b2b41479	2023-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Proficient Rx LP	2917ba32-3355-4d64-966a-8518e6fafdbe	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Asclemed USA, Inc.	4e476c33-3590-4c6f-981d-915623cdacf0	2022-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Proficient Rx LP	57ac12ed-27f0-4f5c-96ae-a7433714b429	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076343 application number: ANDA076343
Topiramate	TOPIRAMATE	Proficient Rx LP	efc0d85e-fddc-4122-85b2-da2d2cb2f9d8	2019-11-01	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
199888	topiramate 25 MG Oral Tablet	PSN	490f109f-30cb-0790-e054-00144ff88e88	6
199888	topiramate 25 MG Oral Tablet	SCD	490f109f-30cb-0790-e054-00144ff88e88	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1971-3	68071197103	30 TABLET in 1 BOTTLE (68071-1971-3)	30 tablet	2017-02-21	0000-00-00	No	No	Current
68071-1971-6	68071197106	60 TABLET in 1 BOTTLE (68071-1971-6)	60 tablet	2017-02-21	0000-00-00	No	No	Current
68071-1971-9	68071197109	90 TABLET in 1 BOTTLE (68071-1971-9)	90 tablet	2017-02-21	0000-00-00	No	No	Current