topiramate - 68382-140-14 - (topiramate)

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Drug Information of topiramate

Product NDC: 68382-140
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: 68382-140
Labeler Name: Zydus Pharmaceuticals (USA) Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078235
Marketing Category: ANDA
Start Marketing Date: 20090327

Package Information of topiramate

Package NDC: 68382-140-14
Package Description: 60 TABLET, FILM COATED in 1 BOTTLE (68382-140-14)

NDC Information of topiramate

NDC Code 68382-140-14
Proprietary Name topiramate
Package Description 60 TABLET, FILM COATED in 1 BOTTLE (68382-140-14)
Product NDC 68382-140
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name topiramate
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20090327
Marketing Category Name ANDA
Labeler Name Zydus Pharmaceuticals (USA) 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