Topamax

Product NDC: 50458-640
11-digit product format: 504580640
Labeler code: 50458
Product ID: 50458-640_1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Janssen Pharmaceuticals, Inc.
Application: NDA020505
Marketing category: NDA
Marketing start: 1997-01-01
Substance: TOPIRAMATE
Active strength: 50 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: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Topamax
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOPIRAMATE	50 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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
151226	Internal RxNorm lookup
151227	Internal RxNorm lookup
151228	Internal RxNorm lookup
151229	Internal RxNorm lookup
152855	Internal RxNorm lookup
199888	Internal RxNorm lookup
199889	Internal RxNorm lookup
199890	Internal RxNorm lookup
205315	Internal RxNorm lookup
205316	Internal RxNorm lookup
845478	Internal RxNorm lookup
845479	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
21628112-0c47-11df-95b3-498d55d89593	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	Strength	SPL version
50458-640-65	Topamax	60 in 1 BOTTLE	TABLET, COATED	60		30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-640-65	EA - Each	50458-640	6b315843-b023-4c09-af5a-9989ab1fff8f	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 TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
topiramate	ACTIVE MOIETY	0H73WJJ391	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
cellulose acetate	INACTIVE INGREDIENT	3J2P07GVB6	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
gelatin	INACTIVE INGREDIENT	2G86QN327L	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
povidones	INACTIVE INGREDIENT	FZ989GH94E	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
sorbitan monolaurate	INACTIVE INGREDIENT	6W9PS8B71J	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
water	INACTIVE INGREDIENT	059QF0KO0R	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	14
topiramate	ACTIVE INGREDIENT	0H73WJJ391	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
topiramate	ACTIVE MOIETY	0H73WJJ391	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
water	INACTIVE INGREDIENT	059QF0KO0R	TOPAMAX (TOPIRAMATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	7
topiramate	ACTIVE INGREDIENT	0H73WJJ391	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
topiramate	ACTIVE MOIETY	0H73WJJ391	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	TOPAMAX (TOPIRAMATE) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	2
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
50458-640	TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]	28	Current NDC, Legacy NDC, 1 package rows	20250326_21628112-0c47-11df-95b3-498d55d89593.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 ndc (product): 50458-640

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	21628112-0c47-11df-95b3-498d55d89593	30
845478	Topamax 15 MG Oral Sprinkle Capsule	PSN	21628112-0c47-11df-95b3-498d55d89593	30
151229	Topamax 200 MG Oral Tablet	PSN	21628112-0c47-11df-95b3-498d55d89593	30
845479	Topamax 25 MG Oral Sprinkle Capsule	PSN	21628112-0c47-11df-95b3-498d55d89593	30
152855	Topamax 25 MG Oral Tablet	PSN	21628112-0c47-11df-95b3-498d55d89593	30
151227	Topamax 50 MG Oral Tablet	PSN	21628112-0c47-11df-95b3-498d55d89593	30
199889	topiramate 100 MG Oral Tablet	PSN	21628112-0c47-11df-95b3-498d55d89593	30
205316	topiramate 15 MG Oral Capsule	PSN	21628112-0c47-11df-95b3-498d55d89593	30
199890	topiramate 200 MG Oral Tablet	PSN	21628112-0c47-11df-95b3-498d55d89593	30
205315	topiramate 25 MG Oral Capsule	PSN	21628112-0c47-11df-95b3-498d55d89593	30
199888	topiramate 25 MG Oral Tablet	PSN	21628112-0c47-11df-95b3-498d55d89593	30
151226	topiramate 50 MG Oral Tablet	PSN	21628112-0c47-11df-95b3-498d55d89593	30
151228	topiramate 100 MG Oral Tablet [Topamax]	SBD	21628112-0c47-11df-95b3-498d55d89593	30
845478	topiramate 15 MG Oral Capsule [Topamax]	SBD	21628112-0c47-11df-95b3-498d55d89593	30
151229	topiramate 200 MG Oral Tablet [Topamax]	SBD	21628112-0c47-11df-95b3-498d55d89593	30
845479	topiramate 25 MG Oral Capsule [Topamax]	SBD	21628112-0c47-11df-95b3-498d55d89593	30
152855	topiramate 25 MG Oral Tablet [Topamax]	SBD	21628112-0c47-11df-95b3-498d55d89593	30
151227	topiramate 50 MG Oral Tablet [Topamax]	SBD	21628112-0c47-11df-95b3-498d55d89593	30
199889	topiramate 100 MG Oral Tablet	SCD	21628112-0c47-11df-95b3-498d55d89593	30
205316	topiramate 15 MG Oral Capsule	SCD	21628112-0c47-11df-95b3-498d55d89593	30
199890	topiramate 200 MG Oral Tablet	SCD	21628112-0c47-11df-95b3-498d55d89593	30
205315	topiramate 25 MG Oral Capsule	SCD	21628112-0c47-11df-95b3-498d55d89593	30
199888	topiramate 25 MG Oral Tablet	SCD	21628112-0c47-11df-95b3-498d55d89593	30
151226	topiramate 50 MG Oral Tablet	SCD	21628112-0c47-11df-95b3-498d55d89593	30
151228	Topamax 100 MG Oral Tablet	SY	21628112-0c47-11df-95b3-498d55d89593	30
845478	Topamax 15 MG Oral Capsule	SY	21628112-0c47-11df-95b3-498d55d89593	30
151229	Topamax 200 MG Oral Tablet	SY	21628112-0c47-11df-95b3-498d55d89593	30
845479	Topamax 25 MG Oral Capsule	SY	21628112-0c47-11df-95b3-498d55d89593	30
152855	Topamax 25 MG Oral Tablet	SY	21628112-0c47-11df-95b3-498d55d89593	30
151227	Topamax 50 MG Oral Tablet	SY	21628112-0c47-11df-95b3-498d55d89593	30
151228	Topamax 100 MG Oral Tablet	PSN	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
151229	Topamax 200 MG Oral Tablet	PSN	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
152855	Topamax 25 MG Oral Tablet	PSN	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
151227	Topamax 50 MG Oral Tablet	PSN	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
199889	topiramate 100 MG Oral Tablet	PSN	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
199890	topiramate 200 MG Oral Tablet	PSN	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
199888	topiramate 25 MG Oral Tablet	PSN	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
151226	topiramate 50 MG Oral Tablet	PSN	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
151228	topiramate 100 MG Oral Tablet [Topamax]	SBD	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
151229	topiramate 200 MG Oral Tablet [Topamax]	SBD	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
152855	topiramate 25 MG Oral Tablet [Topamax]	SBD	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
151227	topiramate 50 MG Oral Tablet [Topamax]	SBD	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
199889	topiramate 100 MG Oral Tablet	SCD	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
199890	topiramate 200 MG Oral Tablet	SCD	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
199888	topiramate 25 MG Oral Tablet	SCD	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
151226	topiramate 50 MG Oral Tablet	SCD	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
151228	Topamax 100 MG Oral Tablet	SY	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
151229	Topamax 200 MG Oral Tablet	SY	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
152855	Topamax 25 MG Oral Tablet	SY	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
151227	Topamax 50 MG Oral Tablet	SY	88c9d1ca-f3a8-4078-8de7-21fd9040dd20	2
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	Marketing start	Marketing end	Sample	Exclude flag	Status
50458-640-65	50458064065	60 TABLET, COATED in 1 BOTTLE (50458-640-65)	1997-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topamax	Janssen Pharmaceuticals, Inc. \| Janssen Ortho, LLC \| Cilag AG	2026-03-12	HUMAN PRESCRIPTION DRUG LABEL	30
Topamax	PD-Rx Pharmaceuticals, Inc.	2022-03-11	HUMAN PRESCRIPTION DRUG LABEL	21
Topamax	REMEDYREPACK INC.	2019-07-03	HUMAN PRESCRIPTION DRUG LABEL	1
Topamax	Physicians Total Care, Inc.	2012-02-14	HUMAN PRESCRIPTION DRUG LABEL	2
Topamax	Rebel Distributors Corp	2010-12-27	HUMAN PRESCRIPTION DRUG LABEL	1