| Product NDC: | 0078-0499 |
| Proprietary Name: | Lamisil |
| Non Proprietary Name: | terbinafine hydrochloride |
| Active Ingredient(s): | 125 mg/1 & nbsp; terbinafine hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | GRANULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0078-0499 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022071 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20070928 |
| Package NDC: | 0078-0499-58 |
| Package Description: | 14 PACKET in 1 CARTON (0078-0499-58) > 1 GRANULE in 1 PACKET (0078-0499-62) |
| NDC Code | 0078-0499-58 |
| Proprietary Name | Lamisil |
| Package Description | 14 PACKET in 1 CARTON (0078-0499-58) > 1 GRANULE in 1 PACKET (0078-0499-62) |
| Product NDC | 0078-0499 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | terbinafine hydrochloride |
| Dosage Form Name | GRANULE |
| Route Name | ORAL |
| Start Marketing Date | 20070928 |
| Marketing Category Name | NDA |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | TERBINAFINE HYDROCHLORIDE |
| Strength Number | 125 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] |