Topiramate - 51079-728-20 - (topiramate)

Alphabetical Index


Drug Information of Topiramate

Product NDC: 51079-728
Proprietary Name: Topiramate
Non Proprietary Name: topiramate
Active Ingredient(s): 100    mg/1 & nbsp;   topiramate
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Topiramate

Product NDC: 51079-728
Labeler Name: Mylan Institutional Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA076314
Marketing Category: ANDA
Start Marketing Date: 20120105

Package Information of Topiramate

Package NDC: 51079-728-20
Package Description: 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-728-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-728-01)

NDC Information of Topiramate

NDC Code 51079-728-20
Proprietary Name Topiramate
Package Description 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-728-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-728-01)
Product NDC 51079-728
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name topiramate
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20120105
Marketing Category Name ANDA
Labeler Name Mylan Institutional Inc.
Substance Name TOPIRAMATE
Strength Number 100
Strength Unit mg/1
Pharmaceutical Classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

Complete Information of Topiramate


General Information