NDC Code | 61269-485-10 |
Package Description | 1 BOTTLE, GLASS in 1 CARTON (61269-485-10) / 100 mL in 1 BOTTLE, GLASS |
Product NDC | 61269-485 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Valcyte |
Non-Proprietary Name | Valganciclovir Hydrochloride |
Dosage Form | POWDER, FOR SOLUTION |
Usage | ORAL |
Start Marketing Date | 20090828 |
Marketing Category Name | NDA |
Application Number | NDA022257 |
Manufacturer | H2-Pharma, LLC |
Substance Name | VALGANCICLOVIR HYDROCHLORIDE |
Strength | 50 |
Strength Unit | mg/mL |
Pharmacy Classes | Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT] |