topiramate

Product NDC: 50090-2248
11-digit product format: 500902248
Labeler code: 50090
Product ID: 50090-2248_36a35600-dfcb-47be-aa06-22ba531f0921
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA090162
Marketing category: ANDA
Marketing start: 2013-07-01
Marketing end: 0000-00-00
Substance: TOPIRAMATE
Active strength: 100 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: No
Listing certified through: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-2248		D	Discontinued by firm	2026-08-03
excluded package	package	50090-2248	50090-2248-0	D	Discontinued by firm	2026-08-03
excluded package	package	50090-2248	50090-2248-1	D	Discontinued by firm	2026-08-03
excluded package	package	50090-2248	50090-2248-2	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 1 · 48 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	50090-2248-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-2248-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-2248-2	`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	50090-2248-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-2248-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-2248-2	`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	50090-2248-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-2248-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-2248-2	`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	50090-2248-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-2248-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-2248-2	`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	50090-2248-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-2248-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-2248-2	`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	50090-2248-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-2248-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-2248-2	`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	50090-2248-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-2248-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-2248-2	`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	50090-2248-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-2248-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-2248-2	`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	50090-2248-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-2248-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-2248-2	`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	50090-2248-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-2248-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-2248-2	`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	50090-2248-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-2248-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-2248-2	`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	50090-2248-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-2248-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-2248-2	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A090162-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27
A090162-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27
A090162-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27
A090162-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090162-001	AB
A090162-002	AB
A090162-003	AB
A090162-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090162-001	TOPIRAMATE	25MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-002	TOPIRAMATE	50MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-003	TOPIRAMATE	100MG	TABLET / ORAL	AB	2009-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-004	TOPIRAMATE	200MG	TABLET / ORAL	AB	2013-02-19	`d06236e962d9…`

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	A090162-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090162-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090162-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090162-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090162-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090162-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090162-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090162-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090162-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090162-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090162-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090162-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090162-004	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-2248-0	topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60	25
50090-2248-1	topiramate	30 in 1 BOTTLE	TABLET, FILM COATED	30	25
50090-2248-2	topiramate	90 in 1 BOTTLE	TABLET, FILM COATED	90	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2248-0	EA - Each	50090-2248	61ab068d-792c-42e8-a3d4-436fa0f9285e	1	2019-02-13
50090-2248-1	EA - Each	50090-2248	30296c07-90ad-4329-8a9d-c04511693752	1	2019-02-13
50090-2248-2	EA - Each	50090-2248	995c4433-4e72-4412-ab2e-86016b8bde35	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2248	TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	22	Legacy NDC, 3 package rows	20241010_a5cffe7a-fdee-487a-bafb-a2d43e76c23c.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 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topiramate	TOPIRAMATE	St. Mary's Medical Park Pharmacy	46a305cb-ab73-0bca-e063-6294a90a9b85	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	12cd9be8-c5c2-4a16-9164-87963e22a88e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Coupler LLC	52ba9c4f-e7d0-4352-e063-6394a90af7e2	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Coupler LLC	50b10a3d-883c-8891-e063-6394a90a86a1	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Unichem Pharmaceuticals (USA), Inc.	6ee00e82-799d-445e-b658-a9712c49a28e	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	REMEDYREPACK INC.	be14624b-7eb9-4e7a-9274-1bb88270ecbe	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	4b1d3130-cf3c-d7da-e063-6294a90a6079	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	68b22d22-c2d3-4e90-b302-56f7cb731427	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	A-S Medication Solutions	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162 ndc (product): 50090-2248
topiramate	TOPIRAMATE	A-S Medication Solutions	c6918801-f22c-4ba4-a396-da484d4334ca	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	49701840-5a32-4ac1-8b07-5c61decacb95	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	bf732c34-9078-496a-8093-f68594e76fcb	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	02cac021-e135-483f-bb5d-f3696eef0682	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	c320999e-b940-44d8-bf31-2fb78835ac2d	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Bryant Ranch Prepack	073d075d-d019-4834-b55d-9b9587914975	2025-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	30ca2fce-4e4c-439e-e063-6294a90af076	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	bbf0f882-1dcc-415d-82bb-acc64f4dc2bc	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	288d6b40-8c87-4f16-85a7-86166b5ac77f	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	2cf7ce9e-afc2-f94e-e063-6394a90a35d0	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162
topiramate	TOPIRAMATE	Preferred Pharmaceuticals Inc.	521be3f1-3ee7-45c7-9f0c-17e08b6c8fca	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090162 application number: ANDA090162

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	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
199888	topiramate 25 MG Oral Tablet	PSN	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
151226	topiramate 50 MG Oral Tablet	PSN	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
199889	topiramate 100 MG Oral Tablet	SCD	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
199888	topiramate 25 MG Oral Tablet	SCD	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25
151226	topiramate 50 MG Oral Tablet	SCD	a5cffe7a-fdee-487a-bafb-a2d43e76c23c	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-2248-0	50090224800	60 TABLET, FILM COATED in 1 BOTTLE (50090-2248-0)	2015-12-03	0000-00-00	No	No	Current
50090-2248-1	50090224801	30 TABLET, FILM COATED in 1 BOTTLE (50090-2248-1)	2015-12-03	0000-00-00	No	No	Current
50090-2248-2	50090224802	90 TABLET, FILM COATED in 1 BOTTLE (50090-2248-2)	2015-12-03	0000-00-00	No	No	Current