NDC Code | 63323-125-94 |
Package Description | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-94) > 25 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 63323-125 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Gemcitabine |
Non-Proprietary Name | Gemcitabine |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Usage | INTRAVENOUS |
Start Marketing Date | 20110726 |
Marketing Category Name | ANDA |
Application Number | ANDA090799 |
Manufacturer | Fresenius Kabi USA, LLC |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Strength | 1 |
Strength Unit | g/25mL |
Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |