| Product NDC: | 0078-0539 |
| Proprietary Name: | Tyzeka |
| Non Proprietary Name: | telbivudine |
| Active Ingredient(s): | 20 mg/mL & nbsp; telbivudine |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0078-0539 |
| Labeler Name: | Novartis Pharmaceuticals Corporation |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022154 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090428 |
| Package NDC: | 0078-0539-85 |
| Package Description: | 300 mL in 1 BOTTLE (0078-0539-85) |
| NDC Code | 0078-0539-85 |
| Proprietary Name | Tyzeka |
| Package Description | 300 mL in 1 BOTTLE (0078-0539-85) |
| Product NDC | 0078-0539 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | telbivudine |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20090428 |
| Marketing Category Name | NDA |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | TELBIVUDINE |
| Strength Number | 20 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] |