TOPIRAMATE

Product NDC: 13668-033
11-digit product format: 136680033
Labeler code: 13668
Product ID: 13668-033_16ea5453-3213-4fef-9918-92f5c7179798
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA079153
Marketing category: ANDA
Marketing start: 2009-03-27
Marketing end: 0000-00-00
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: 2024-12-31
Current FDA listing: Historical FDA.report record

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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13668-033		D	Discontinued by firm	2026-08-03
excluded package	package	13668-033	13668-033-01	D	Discontinued by firm	2026-08-03
excluded package	package	13668-033	13668-033-05	D	Discontinued by firm	2026-08-03
excluded package	package	13668-033	13668-033-31	D	Discontinued by firm	2026-08-03
excluded package	package	13668-033	13668-033-60	D	Discontinued by firm	2026-08-03
excluded package	package	13668-033	13668-033-64	D	Discontinued by firm	2026-08-03

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 2 · 72 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-033-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-033-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-033-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-033-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-033-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-033-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-033-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-033-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-033-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-033-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-033-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-033-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-033-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-033-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-033-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-033-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-033-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-033-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-033-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-033-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-033-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-033-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-033-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-033-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-033-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-033-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-033-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-033-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-033-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13668-033-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-033-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-033-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-033-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-033-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13668-033-64	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-033-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-033-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-033-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-033-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13668-033-64	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-033-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-033-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-033-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-033-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13668-033-64	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-033-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-033-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-033-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-033-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13668-033-64	`ad56d346431e…`	`cc804d4bbf1e…`

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	Approval date
A079153-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27
A079153-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27
A079153-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27
A079153-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A079153-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079153-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079153-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079153-004	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A079153-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079153-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079153-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079153-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079153-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079153-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079153-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079153-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079153-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079153-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079153-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079153-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079153-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079153-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079153-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079153-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079153-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079153-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079153-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079153-004	AB	1	`ea99ee380514…`

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-033-01	EA - Each	13668-033	651dde5d-6e53-4c77-8270-699106da6305	1	2012-07-24
13668-033-05	EA - Each	13668-033	de867dd9-963d-401f-b806-1f271a14af65	1	2012-07-24
13668-033-60	EA - Each	13668-033	fed986bf-73c7-4385-8e5b-c832f1d117d3	1	2012-07-24
13668-033-64	EA - Each	13668-033	5a669728-2f9e-4934-b467-e14fa47f2ca3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]	10
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET [STAT RX USA LLC]	3
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET [STAT RX USA LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET [STAT RX USA LLC]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPIRAMATE TABLET [STAT RX USA LLC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TOPIRAMATE TABLET [STAT RX USA LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPIRAMATE TABLET [STAT RX USA LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPIRAMATE TABLET [STAT RX USA LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET [STAT RX USA LLC]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TOPIRAMATE TABLET [STAT RX USA LLC]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET [STAT RX USA LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE TABLET [STAT RX USA LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET [STAT RX USA LLC]	3
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]	1

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	efd1106b-d369-4651-b703-b0985ce93b79	3
199888	topiramate 25 MG Oral Tablet	PSN	efd1106b-d369-4651-b703-b0985ce93b79	3
151226	topiramate 50 MG Oral Tablet	PSN	efd1106b-d369-4651-b703-b0985ce93b79	3
199889	topiramate 100 MG Oral Tablet	SCD	efd1106b-d369-4651-b703-b0985ce93b79	3
199888	topiramate 25 MG Oral Tablet	SCD	efd1106b-d369-4651-b703-b0985ce93b79	3
151226	topiramate 50 MG Oral Tablet	SCD	efd1106b-d369-4651-b703-b0985ce93b79	3
199889	topiramate 100 MG Oral Tablet	PSN	0f686676-8d66-4f29-966c-0a31e2eee90c	1
199889	topiramate 100 MG Oral Tablet	SCD	0f686676-8d66-4f29-966c-0a31e2eee90c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-033-01	13668003301	100 TABLET in 1 BOTTLE (13668-033-01)	100 tablet	2009-03-27	0000-00-00	No	No	Current
13668-033-05	13668003305	500 TABLET in 1 BOTTLE (13668-033-05)	500 tablet	2009-03-27	0000-00-00	No	No	Current
13668-033-31	13668003331	2500 TABLET in 1 BOTTLE (13668-033-31)	2500 tablet	2009-03-27	0000-00-00	No	No	Current
13668-033-60	13668003360	60 TABLET in 1 BOTTLE (13668-033-60)	60 tablet	2009-03-27	0000-00-00	No	No	Current
13668-033-64	13668003364	90 TABLET in 1 DOSE PACK (13668-033-64)	90 tablet	2009-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOPIRAMATE	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	19
TOPIRAMATE- topiramate tablet	DIRECT RX	2015-06-24	HUMAN PRESCRIPTION DRUG LABEL	1
TOPIRAMATE	STAT Rx USA LLC	2011-12-22	HUMAN PRESCRIPTION DRUG LABEL	3