TOPIRAMATE

Product NDC: 52959-643
11-digit product format: 529590643
Labeler code: 52959
Product ID: 52959-643_1e56d689-84c0-41f2-a236-b02329ad276a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TOPIRAMATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA090278
Marketing category: ANDA
Marketing start: 2009-03-27
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: 2019-12-31
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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-643-30	2020-01-31	C162847	48780-1	9d75b9d1-0a68-f424-e053-dadaa90a57ce	Topiramate Tablets
52959-643-60	2020-01-31	C162847	48780-1	9d75b9d1-0a68-f424-e053-dadaa90a57ce	Topiramate Tablets
52959-643-90	2020-01-31	C162847	48780-1	9d75b9d1-0a68-f424-e053-dadaa90a57ce	Topiramate Tablets

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-643-30	TOPIRAMATE	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
52959-643-60	TOPIRAMATE	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
52959-643-90	TOPIRAMATE	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-643-30	EA - Each	52959-643	852d6102-c48a-4d51-b6d6-6759a2c24f28	1	2013-02-13
52959-643-60	EA - Each	52959-643	be285676-8476-4ea2-a1af-5012ed1e9851	1	2013-02-13
52959-643-90	EA - Each	52959-643	8a04f5af-f462-425c-b98e-39d904880d37	1	2017-03-06

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-643	TOPIRAMATE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 3 package rows	20120824_6b5b0d58-bfa0-41c8-955f-e74f89506d1e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0H73WJJ391	TOPIRAMATE	97240-79-4	TOPIRAMATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199889	topiramate 100 MG Oral Tablet	PSN	6b5b0d58-bfa0-41c8-955f-e74f89506d1e	2
199889	topiramate 100 MG Oral Tablet	SCD	6b5b0d58-bfa0-41c8-955f-e74f89506d1e	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-643-30	52959064330	30 in 1 BOTTLE	Historical
52959-643-60	52959064360	60 in 1 BOTTLE	Historical
52959-643-90	52959064390	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topiramate Tablets	H.J. Harkins Company, Inc. \| Sun Pharmaceutical Industries	2012-07-19	HUMAN PRESCRIPTION DRUG LABEL	2