Product NDC: | 13913-005 |
Proprietary Name: | Gralise |
Non Proprietary Name: | gabapentin |
Active Ingredient(s): | 600 mg/1 & nbsp; gabapentin |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 13913-005 |
Labeler Name: | Depomed, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022544 |
Marketing Category: | NDA |
Start Marketing Date: | 20110128 |
Package NDC: | 13913-005-19 |
Package Description: | 90 TABLET, FILM COATED in 1 BOTTLE (13913-005-19) |
NDC Code | 13913-005-19 |
Proprietary Name | Gralise |
Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (13913-005-19) |
Product NDC | 13913-005 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | gabapentin |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20110128 |
Marketing Category Name | NDA |
Labeler Name | Depomed, Inc. |
Substance Name | GABAPENTIN |
Strength Number | 600 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |