Product NDC: | 0078-0508 |
Proprietary Name: | Tegretol |
Non Proprietary Name: | carbamazepine |
Active Ingredient(s): | 100 mg/5mL & nbsp; carbamazepine |
Administration Route(s): | ORAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0508 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA018927 |
Marketing Category: | NDA |
Start Marketing Date: | 19871218 |
Package NDC: | 0078-0508-83 |
Package Description: | 450 mL in 1 BOTTLE (0078-0508-83) |
NDC Code | 0078-0508-83 |
Proprietary Name | Tegretol |
Package Description | 450 mL in 1 BOTTLE (0078-0508-83) |
Product NDC | 0078-0508 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | carbamazepine |
Dosage Form Name | SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 19871218 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | CARBAMAZEPINE |
Strength Number | 100 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] |