Horizant - 53451-0101-1 - (gabapentin enacarbil)

Alphabetical Index


Drug Information of Horizant

Product NDC: 53451-0101
Proprietary Name: Horizant
Non Proprietary Name: gabapentin enacarbil
Active Ingredient(s): 600    mg/1 & nbsp;   gabapentin enacarbil
Administration Route(s): ORAL
Dosage Form(s): TABLET, EXTENDED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of Horizant

Product NDC: 53451-0101
Labeler Name: XenoPort Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022399
Marketing Category: NDA
Start Marketing Date: 20130501

Package Information of Horizant

Package NDC: 53451-0101-1
Package Description: 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1)

NDC Information of Horizant

NDC Code 53451-0101-1
Proprietary Name Horizant
Package Description 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1)
Product NDC 53451-0101
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name gabapentin enacarbil
Dosage Form Name TABLET, EXTENDED RELEASE
Route Name ORAL
Start Marketing Date 20130501
Marketing Category Name NDA
Labeler Name XenoPort Inc.
Substance Name GABAPENTIN ENACARBIL
Strength Number 600
Strength Unit mg/1
Pharmaceutical Classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

Complete Information of Horizant


General Information