Topamax - 50458-645-65 - (topiramate)

Alphabetical Index


Drug Information of Topamax

Product NDC: 50458-645
Proprietary Name: Topamax
Non Proprietary Name: topiramate
Active Ingredient(s): 25    mg/1 & nbsp;   topiramate
Administration Route(s): ORAL
Dosage Form(s): CAPSULE, COATED PELLETS
Coding System: National Drug Codes(NDC)

Labeler Information of Topamax

Product NDC: 50458-645
Labeler Name: Janssen Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020844
Marketing Category: NDA
Start Marketing Date: 19981101

Package Information of Topamax

Package NDC: 50458-645-65
Package Description: 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65)

NDC Information of Topamax

NDC Code 50458-645-65
Proprietary Name Topamax
Package Description 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65)
Product NDC 50458-645
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name topiramate
Dosage Form Name CAPSULE, COATED PELLETS
Route Name ORAL
Start Marketing Date 19981101
Marketing Category Name NDA
Labeler Name Janssen Pharmaceuticals, Inc.
Substance Name TOPIRAMATE
Strength Number 25
Strength Unit mg/1
Pharmaceutical Classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

Complete Information of Topamax


General Information