Topiramate

Product NDC: 71610-193
11-digit product format: 716100193
Labeler code: 71610
Product ID: 71610-193_8983a5e5-b9d5-40d1-8efb-8b3f8919cad2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: topiramate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA079162
Marketing category: ANDA
Marketing start: 2011-07-08
Marketing end: 0000-00-00
Substance: TOPIRAMATE
Active strength: 50 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: 2020-12-31
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
71610-193-53	2023-01-30	C162847	48780-1	f386c64a-0f63-0266-e053-dadaa90a7c1a	TOPIRAMATE TABS These highlights do not include all the information needed to use [topiramate tablets, USP] safely and effectively. See full prescribing information for[topiramate tablets, USP] Initial U.S. Approval:[1996]

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-193-53	Topiramate	60 in 1 BOTTLE	TABLET	60		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-193	TOPIRAMATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 1 package rows	20190109_7b630268-906b-4c75-bb98-99957e3a7072.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
151226	topiramate 50 MG Oral Tablet	PSN	7b630268-906b-4c75-bb98-99957e3a7072	2
151226	topiramate 50 MG Oral Tablet	SCD	7b630268-906b-4c75-bb98-99957e3a7072	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-193-53	71610019353	60 TABLET in 1 BOTTLE (71610-193-53)	60 tablet	2018-11-13	0000-00-00	No	No	Current