Topiramate

Product NDC: 50436-9952
11-digit product format: 504369952
Labeler code: 50436
Product ID: 50436-9952_72ead1c8-4794-4510-b056-a16682da2f76
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Topiramate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA090278
Marketing category: ANDA
Marketing start: 2009-03-27
Marketing end: 0000-00-00
Substance: TOPIRAMATE
Active strength: 200 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
50436-9952-2	2021-01-29	C162847	48780-1	ba0f9c33-36c6-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use TOPIRAMATE tablets safely and effectively. See full prescribing information for TOPIRAMATE tablets, USP. TOPIRAMATE tablets, USP for oral use Initial U.S. Approval: 1996

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-9952-2	Topiramate	60 in 1 BOTTLE	TABLET, FILM COATED	60		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-9952	TOPIRAMATE TABLET, FILM COATED [UNIT DOSE SERVICES]	4	Legacy NDC, 1 package rows	20170312_5f03d5e8-8f65-42cd-bbef-707def83905c.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
199890	topiramate 200 MG Oral Tablet	PSN	5f03d5e8-8f65-42cd-bbef-707def83905c	4
199890	topiramate 200 MG Oral Tablet	SCD	5f03d5e8-8f65-42cd-bbef-707def83905c	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-9952-2	50436995202	60 in 1 BOTTLE	Historical