Topiramate - 68084-344-01 - (Topiramate)

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Drug Information of Topiramate

Product NDC: 68084-344
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: 68084-344
Labeler Name: American Health Packaging
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078235
Marketing Category: ANDA
Start Marketing Date: 20120601

Package Information of Topiramate

Package NDC: 68084-344-01
Package Description: 10 BLISTER PACK in 1 CARTON (68084-344-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68084-344-11)

NDC Information of Topiramate

NDC Code 68084-344-01
Proprietary Name Topiramate
Package Description 10 BLISTER PACK in 1 CARTON (68084-344-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68084-344-11)
Product NDC 68084-344
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Topiramate
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20120601
Marketing Category Name ANDA
Labeler Name American Health Packaging
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