Topiramate - 68387-559-60 - (TOPIRAMATE)

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Drug Information of Topiramate

Product NDC: 68387-559
Proprietary Name: Topiramate
Non Proprietary Name: TOPIRAMATE
Active Ingredient(s): 100    mg/1 & nbsp;   TOPIRAMATE
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Topiramate

Product NDC: 68387-559
Labeler Name: Keltman Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA079162
Marketing Category: ANDA
Start Marketing Date: 20100730

Package Information of Topiramate

Package NDC: 68387-559-60
Package Description: 60 TABLET in 1 BOTTLE, PLASTIC (68387-559-60)

NDC Information of Topiramate

NDC Code 68387-559-60
Proprietary Name Topiramate
Package Description 60 TABLET in 1 BOTTLE, PLASTIC (68387-559-60)
Product NDC 68387-559
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name TOPIRAMATE
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20100730
Marketing Category Name ANDA
Labeler Name Keltman Pharmaceuticals 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