Topiramate - 52125-089-02 - (Topiramate)

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Drug Information of Topiramate

Product NDC: 52125-089
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: 52125-089
Labeler Name: REMEDYREPACK INC.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA077627
Marketing Category: ANDA
Start Marketing Date: 20130308

Package Information of Topiramate

Package NDC: 52125-089-02
Package Description: 30 TABLET, FILM COATED in 1 BLISTER PACK (52125-089-02)

NDC Information of Topiramate

NDC Code 52125-089-02
Proprietary Name Topiramate
Package Description 30 TABLET, FILM COATED in 1 BLISTER PACK (52125-089-02)
Product NDC 52125-089
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Topiramate
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20130308
Marketing Category Name ANDA
Labeler Name REMEDYREPACK 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