| 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] |