| NDC Code | 55390-391-10 |
| Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (55390-391-10) > 5 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 55390-391 |
| 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 | 20120319 |
| Marketing Category Name | ANDA |
| Application Number | ANDA091365 |
| Manufacturer | Bedford Laboratories |
| Substance Name | GEMCITABINE HYDROCHLORIDE |
| Strength | 40 |
| Strength Unit | mg/mL |
| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |