Topiramate

Product NDC: 53217-329
11-digit product format: 532170329
Labeler code: 53217
Product ID: 53217-329_5dc7143a-871d-47e7-9a3e-b60d648c2276
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA076343
Marketing category: ANDA
Marketing start: 2017-07-11
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
53217-329-60	2020-01-31	C162847	48780-1	9d75b9cf-fa88-f424-e053-dadaa90a57ce	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, for oral Use. Initial U.S. Approval: 1996

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-329-60	Topiramate	60 in 1 BOTTLE	TABLET	60		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-329	TOPIRAMATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180523_1770f22c-9a80-4be5-ae77-9537ea25990f.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	1770f22c-9a80-4be5-ae77-9537ea25990f	1
199889	topiramate 100 MG Oral Tablet	SCD	1770f22c-9a80-4be5-ae77-9537ea25990f	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-329-60	53217032960	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topiramate	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-05-22	HUMAN PRESCRIPTION DRUG LABEL	1