topiramate - 29300-116-10 - (topiramate)

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Drug Information of topiramate

Product NDC: 29300-116
Proprietary Name: topiramate
Non Proprietary Name: topiramate
Active Ingredient(s): 50    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: 29300-116
Labeler Name: Unichem Pharmaceuticals (USA), Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090162
Marketing Category: ANDA
Start Marketing Date: 20130701

Package Information of topiramate

Package NDC: 29300-116-10
Package Description: 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-116-10)

NDC Information of topiramate

NDC Code 29300-116-10
Proprietary Name topiramate
Package Description 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-116-10)
Product NDC 29300-116
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name topiramate
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20130701
Marketing Category Name ANDA
Labeler Name Unichem Pharmaceuticals (USA), Inc.
Substance Name TOPIRAMATE
Strength Number 50
Strength Unit mg/1
Pharmaceutical Classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

Complete Information of topiramate


General Information