Topamax

Product NDC: 50458-641
11-digit product format: 504580641
Labeler code: 50458
Product ID: 50458-641_d7103f8b-d7c0-4809-8902-85174c517c8e
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: 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 264 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
2026-10-15 13:18:30	2026-09	N020505-001	TOPAMAX	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020505-002	TOPAMAX	200MG	TABLET / ORAL	AB	RLD	1996-12-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020505-003	TOPAMAX	300MG	TABLET / ORAL			1996-12-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020505-004	TOPAMAX	25MG	TABLET / ORAL	AB	RLD	1996-12-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020505-005	TOPAMAX	50MG	TABLET / ORAL	AB	RLD	1996-12-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020505-006	TOPAMAX	400MG	TABLET / ORAL			1996-12-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020505-001	TOPAMAX	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020505-002	TOPAMAX	200MG	TABLET / ORAL	AB	RLD	1996-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020505-003	TOPAMAX	300MG	TABLET / ORAL			1996-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020505-004	TOPAMAX	25MG	TABLET / ORAL	AB	RLD	1996-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020505-005	TOPAMAX	50MG	TABLET / ORAL	AB	RLD	1996-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020505-006	TOPAMAX	400MG	TABLET / ORAL			1996-12-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020505-001	TOPAMAX	100MG	TABLET / ORAL	AB	RLD, RS	1996-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020505-002	TOPAMAX	200MG	TABLET / ORAL	AB	RLD	1996-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020505-003	TOPAMAX	300MG	TABLET / ORAL			1996-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020505-004	TOPAMAX	25MG	TABLET / ORAL	AB	RLD	1996-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020505-005	TOPAMAX	50MG	TABLET / ORAL	AB	RLD	1996-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020505-006	TOPAMAX	400MG	TABLET / ORAL			1996-12-24	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020505-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020505-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020505-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020505-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020505-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020505-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020505-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020505-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020505-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020505-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020505-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020505-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020505-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020505-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020505-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020505-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020505-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020505-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020505-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020505-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020505-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020505-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020505-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020505-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020505-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020505-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020505-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020505-005	AB	1	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOPIRAMATE	100 mg/1

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
50458-641-65	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
50458-641-65	EA - Each	50458-641	bdd8a19b-133c-4a8a-80fd-34c82dfbba85	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 [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
50458-641	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

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
50458-641-65	50458064165	60 TABLET, COATED in 1 BOTTLE (50458-641-65)	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 \| Siegfried AG	2026-03-12	HUMAN PRESCRIPTION DRUG LABEL	31
Topamax	REMEDYREPACK INC.	2019-09-17	HUMAN PRESCRIPTION DRUG LABEL	3
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