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