Product NDC: | 0078-0456 |
Proprietary Name: | Trileptal |
Non Proprietary Name: | oxcarbazepine |
Active Ingredient(s): | 150 mg/1 & nbsp; oxcarbazepine |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0456 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021014 |
Marketing Category: | NDA |
Start Marketing Date: | 20000130 |
Package NDC: | 0078-0456-35 |
Package Description: | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0456-35) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0456-61) |
NDC Code | 0078-0456-35 |
Proprietary Name | Trileptal |
Package Description | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0456-35) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0456-61) |
Product NDC | 0078-0456 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | oxcarbazepine |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20000130 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | OXCARBAZEPINE |
Strength Number | 150 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |