TOPIRAMATE

Product NDC: 52959-441
11-digit product format: 529590441
Labeler code: 52959
Product ID: 52959-441_7e3a6da2-f432-4a62-ab53-c305587b7726
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA079153
Marketing category: ANDA
Marketing start: 2009-03-27
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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-441-01	2019-11-13	C162847	48780-1	97449f38-bd6e-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets Rx Only Initial U.S. Approval - 1996
52959-441-30	2019-11-13	C162847	48780-1	97449f38-bd6e-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets Rx Only Initial U.S. Approval - 1996
52959-441-60	2019-11-13	C162847	48780-1	97449f38-bd6e-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use topiramate tablets safely and effectively. See full prescribing information for topiramate tablets Topiramate Tablets Rx Only Initial U.S. Approval - 1996

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-441-01	TOPIRAMATE	120 in 1 BOTTLE	TABLET	120	3
52959-441-30	TOPIRAMATE	30 in 1 BOTTLE	TABLET	30	3
52959-441-60	TOPIRAMATE	60 in 1 BOTTLE	TABLET	60	3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-441	TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.]	3	Legacy NDC, 3 package rows	20120120_546130a3-e5f2-422d-88f0-66de19540ecb.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
199888	topiramate 25 MG Oral Tablet	PSN	546130a3-e5f2-422d-88f0-66de19540ecb	3
151226	topiramate 50 MG Oral Tablet	PSN	546130a3-e5f2-422d-88f0-66de19540ecb	3
199888	topiramate 25 MG Oral Tablet	SCD	546130a3-e5f2-422d-88f0-66de19540ecb	3
151226	topiramate 50 MG Oral Tablet	SCD	546130a3-e5f2-422d-88f0-66de19540ecb	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-441-01	52959044101	120 in 1 BOTTLE	Historical
52959-441-30	52959044130	30 in 1 BOTTLE	Historical
52959-441-60	52959044160	60 in 1 BOTTLE	Historical