Topiramate

Product NDC: 31722-278
11-digit product format: 317220278
Labeler code: 31722
Product ID: 31722-278_6be89e4b-831c-46d6-a4c0-1c2ab53d2d22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA079162
Marketing category: ANDA
Marketing start: 2011-01-01
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

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
31722-278-05	2020-01-31	C162847	48780-1	9d75b9d0-d17a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral use Initial U.S. Approval: 1996
31722-278-10	2020-01-31	C162847	48780-1	9d75b9d0-d17a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral use Initial U.S. Approval: 1996
31722-278-60	2020-01-31	C162847	48780-1	9d75b9d0-d17a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-278-05	Topiramate	500 in 1 BOTTLE	TABLET	500	5
31722-278-10	Topiramate	1000 in 1 BOTTLE	TABLET	1000	5
31722-278-60	Topiramate	60 in 1 BOTTLE	TABLET	60	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-278-05	EA - Each	31722-278	c8a6ea54-742a-4fe5-b6d0-c1e9b0fff18f	1	2012-07-24
31722-278-10	EA - Each	31722-278	47962fee-d44d-47e8-b4de-6551ec8172ce	1	2012-07-24
31722-278-60	EA - Each	31722-278	b683671e-338d-4fd8-9a48-85e3c7845981	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET [DIRECT RX]	6
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET [DIRECT RX]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET [DIRECT RX]	6
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	TOPIRAMATE TABLET [DIRECT RX]	6
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TOPIRAMATE TABLET [DIRECT RX]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPIRAMATE TABLET [DIRECT RX]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET [DIRECT RX]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TOPIRAMATE TABLET [DIRECT RX]	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPIRAMATE TABLET [DIRECT RX]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPIRAMATE TABLET [DIRECT RX]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET [DIRECT RX]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET [DIRECT RX]	6
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET [UNIT DOSE SERVICES]	2
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
Topiramate	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-278	TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.]	5	Legacy NDC, 3 package rows	20151028_e999cb0a-8e45-4fdc-9b52-f3661f5dfc33.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
199888	topiramate 25 MG Oral Tablet	PSN	e883e5ac-4ee4-466e-bb6c-bff0a5ea8479	8
199888	topiramate 25 MG Oral Tablet	SCD	e883e5ac-4ee4-466e-bb6c-bff0a5ea8479	8
199888	topiramate 25 MG Oral Tablet	PSN	b1ddad60-26ab-49a7-b8a9-96442dc0ac87	6
199888	topiramate 25 MG Oral Tablet	SCD	b1ddad60-26ab-49a7-b8a9-96442dc0ac87	6
199889	topiramate 100 MG Oral Tablet	PSN	e999cb0a-8e45-4fdc-9b52-f3661f5dfc33	5
199890	topiramate 200 MG Oral Tablet	PSN	e999cb0a-8e45-4fdc-9b52-f3661f5dfc33	5
199888	topiramate 25 MG Oral Tablet	PSN	e999cb0a-8e45-4fdc-9b52-f3661f5dfc33	5
151226	topiramate 50 MG Oral Tablet	PSN	e999cb0a-8e45-4fdc-9b52-f3661f5dfc33	5
199889	topiramate 100 MG Oral Tablet	SCD	e999cb0a-8e45-4fdc-9b52-f3661f5dfc33	5
199890	topiramate 200 MG Oral Tablet	SCD	e999cb0a-8e45-4fdc-9b52-f3661f5dfc33	5
199888	topiramate 25 MG Oral Tablet	SCD	e999cb0a-8e45-4fdc-9b52-f3661f5dfc33	5
151226	topiramate 50 MG Oral Tablet	SCD	e999cb0a-8e45-4fdc-9b52-f3661f5dfc33	5
199889	topiramate 100 MG Oral Tablet	PSN	47fd4c44-56fa-4864-af5d-7b65c7b746d7	1
199890	topiramate 200 MG Oral Tablet	PSN	47fd4c44-56fa-4864-af5d-7b65c7b746d7	1
199888	topiramate 25 MG Oral Tablet	PSN	47fd4c44-56fa-4864-af5d-7b65c7b746d7	1
199889	topiramate 100 MG Oral Tablet	SCD	47fd4c44-56fa-4864-af5d-7b65c7b746d7	1
199890	topiramate 200 MG Oral Tablet	SCD	47fd4c44-56fa-4864-af5d-7b65c7b746d7	1
199888	topiramate 25 MG Oral Tablet	SCD	47fd4c44-56fa-4864-af5d-7b65c7b746d7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
31722-278-05	31722027805	500 in 1 BOTTLE	Historical
31722-278-10	31722027810	1000 in 1 BOTTLE	Historical
31722-278-60	31722027860	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topiramate	Unit Dose Services	2019-05-30	HUMAN PRESCRIPTION DRUG LABEL	8
Topiramate	Camber Pharmaceuticals, Inc. \| Ascent Pharmaceuticals, Inc.	2015-10-27	HUMAN PRESCRIPTION DRUG LABEL	5
TOPIRAMATE	DIRECT RX	2015-09-17	HUMAN PRESCRIPTION DRUG LABEL	6
Topiramate	Keltman Pharmaceuticals Inc.	2011-02-15	HUMAN PRESCRIPTION DRUG LABEL	1

Topiramate

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#