Topamax

Product NDC: 21695-128
11-digit product format: 216950128
Labeler code: 21695
Product ID: 21695-128_202b1a2a-11dc-4c3d-aa53-27512a98a042
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA020505
Marketing category: NDA
Marketing start: 1997-01-01
Marketing end: 0000-00-00
Substance: TOPIRAMATE
Active strength: 25 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-128		I	Inactivated by FDA	2026-08-07
excluded package	package	21695-128	21695-128-15	I	Inactivated by FDA	2026-08-07
excluded package	package	21695-128	21695-128-60	I	Inactivated by FDA	2026-08-07

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 · 66 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	21695-128-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-128-15	`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	21695-128-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-128-15	`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	21695-128-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-128-15	`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	21695-128-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-128-15	`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	21695-128-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-128-15	`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	21695-128-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-128-15	`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	21695-128-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-128-15	`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	21695-128-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-128-15	`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	21695-128-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-128-15	`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	21695-128-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-128-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-128-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-128-15	`367a005e9d99…`	`383a685ebd0f…`
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	21695-128-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-128-15	`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	21695-128-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-128-15	`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	21695-128-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-128-15	`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	21695-128-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-128-15	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-128-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-128-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-128-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-128-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-128-60	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-128-15	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-128-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-128-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-128-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-128-15	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020505-001	TOPAMAX	TOPIRAMATE	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24
N020505-002	TOPAMAX	TOPIRAMATE	200MG	TABLET / ORAL	AB	RLD	1996-12-24
N020505-003	TOPAMAX	TOPIRAMATE	300MG	TABLET / ORAL			1996-12-24
N020505-004	TOPAMAX	TOPIRAMATE	25MG	TABLET / ORAL	AB	RLD	1996-12-24
N020505-005	TOPAMAX	TOPIRAMATE	50MG	TABLET / ORAL	AB	RLD	1996-12-24
N020505-006	TOPAMAX	TOPIRAMATE	400MG	TABLET / ORAL			1996-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N020505-001	AB
N020505-002	AB
N020505-004	AB
N020505-005	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 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020505-001	TOPAMAX	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020505-002	TOPAMAX	200MG	TABLET / ORAL	AB	RLD	1996-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020505-003	TOPAMAX	300MG	TABLET / ORAL			1996-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020505-004	TOPAMAX	25MG	TABLET / ORAL	AB	RLD	1996-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020505-005	TOPAMAX	50MG	TABLET / ORAL	AB	RLD	1996-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020505-006	TOPAMAX	400MG	TABLET / ORAL			1996-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020505-001	TOPAMAX	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020505-002	TOPAMAX	200MG	TABLET / ORAL	AB	RLD	1996-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020505-003	TOPAMAX	300MG	TABLET / ORAL			1996-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020505-004	TOPAMAX	25MG	TABLET / ORAL	AB	RLD	1996-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020505-005	TOPAMAX	50MG	TABLET / ORAL	AB	RLD	1996-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020505-006	TOPAMAX	400MG	TABLET / ORAL			1996-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020505-001	TOPAMAX	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020505-002	TOPAMAX	200MG	TABLET / ORAL	AB	RLD	1996-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020505-003	TOPAMAX	300MG	TABLET / ORAL			1996-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020505-004	TOPAMAX	25MG	TABLET / ORAL	AB	RLD	1996-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020505-005	TOPAMAX	50MG	TABLET / ORAL	AB	RLD	1996-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020505-006	TOPAMAX	400MG	TABLET / ORAL			1996-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020505-001	TOPAMAX	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020505-002	TOPAMAX	200MG	TABLET / ORAL	AB	RLD	1996-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020505-003	TOPAMAX	300MG	TABLET / ORAL			1996-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020505-004	TOPAMAX	25MG	TABLET / ORAL	AB	RLD	1996-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020505-005	TOPAMAX	50MG	TABLET / ORAL	AB	RLD	1996-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020505-006	TOPAMAX	400MG	TABLET / ORAL			1996-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020505-001	TOPAMAX	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020505-002	TOPAMAX	200MG	TABLET / ORAL	AB	RLD	1996-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020505-003	TOPAMAX	300MG	TABLET / ORAL			1996-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020505-004	TOPAMAX	25MG	TABLET / ORAL	AB	RLD	1996-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020505-005	TOPAMAX	50MG	TABLET / ORAL	AB	RLD	1996-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020505-006	TOPAMAX	400MG	TABLET / ORAL			1996-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020505-001	TOPAMAX	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020505-002	TOPAMAX	200MG	TABLET / ORAL	AB	RLD	1996-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020505-003	TOPAMAX	300MG	TABLET / ORAL			1996-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020505-004	TOPAMAX	25MG	TABLET / ORAL	AB	RLD	1996-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020505-005	TOPAMAX	50MG	TABLET / ORAL	AB	RLD	1996-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020505-006	TOPAMAX	400MG	TABLET / ORAL			1996-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020505-001	TOPAMAX	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020505-002	TOPAMAX	200MG	TABLET / ORAL	AB	RLD	1996-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020505-003	TOPAMAX	300MG	TABLET / ORAL			1996-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020505-004	TOPAMAX	25MG	TABLET / ORAL	AB	RLD	1996-12-24	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020505-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020505-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020505-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020505-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020505-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020505-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020505-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020505-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020505-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020505-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020505-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020505-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020505-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020505-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020505-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020505-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020505-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020505-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020505-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020505-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020505-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020505-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020505-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020505-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020505-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020505-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020505-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020505-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020505-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020505-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020505-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020505-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020505-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020505-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020505-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020505-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020505-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020505-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020505-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020505-005	AB	1	`d06236e962d9…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-128-15	2019-09-24	C162847	48780-1	934fe258-4cd7-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use TOPAMAX ® safely and effectively. See full prescribing information for TOPAMAX ® TOPAMAX ® (topiramate) TABLETS Initial U.S. Approval: 1996
21695-128-60	2019-09-24	C162847	48780-1	934fe258-4cd7-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use TOPAMAX ® safely and effectively. See full prescribing information for TOPAMAX ® TOPAMAX ® (topiramate) TABLETS Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-128-15	Topamax	15 in 1 BOTTLE	TABLET, COATED	15		1
21695-128-60	Topamax	60 in 1 BOTTLE	TABLET, COATED	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-128-15	EA - Each	21695-128	bdedad0e-2f42-4e42-8098-1dc4d712158b	1	2012-07-24
21695-128-60	EA - Each	21695-128	042df251-af0e-40ee-a393-6f9e2c725715	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
topiramate	ACTIVE INGREDIENT	0H73WJJ391	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
topiramate	ACTIVE MOIETY	0H73WJJ391	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-128	TOPAMAX (TOPIRAMATE) TABLET, COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110104_202b1a2a-11dc-4c3d-aa53-27512a98a042.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topamax	TOPIRAMATE	Janssen Pharmaceuticals, Inc.	21628112-0c47-11df-95b3-498d55d89593	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020505 application number: NDA020505

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
151228	Topamax 100 MG Oral Tablet	PSN	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
152855	Topamax 25 MG Oral Tablet	PSN	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
151227	Topamax 50 MG Oral Tablet	PSN	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
199889	topiramate 100 MG Oral Tablet	PSN	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
199888	topiramate 25 MG Oral Tablet	PSN	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
151226	topiramate 50 MG Oral Tablet	PSN	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
151228	topiramate 100 MG Oral Tablet [Topamax]	SBD	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
152855	topiramate 25 MG Oral Tablet [Topamax]	SBD	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
151227	topiramate 50 MG Oral Tablet [Topamax]	SBD	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
199889	topiramate 100 MG Oral Tablet	SCD	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
199888	topiramate 25 MG Oral Tablet	SCD	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
151226	topiramate 50 MG Oral Tablet	SCD	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
151228	Topamax 100 MG Oral Tablet	SY	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
152855	Topamax 25 MG Oral Tablet	SY	202b1a2a-11dc-4c3d-aa53-27512a98a042	1
151227	Topamax 50 MG Oral Tablet	SY	202b1a2a-11dc-4c3d-aa53-27512a98a042	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-128-15	21695012815	15 in 1 BOTTLE	Historical
21695-128-60	21695012860	60 in 1 BOTTLE	Historical