NDC Code | 0409-0186-01 |
Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0186-01) / 25 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 0409-0186 |
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 | ANDA078339 |
Manufacturer | Hospira, Inc. |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Strength | 38 |
Strength Unit | mg/mL |
Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |