| NDC Code | 45963-612-57 |
| Package Description | 1 VIAL in 1 CARTON (45963-612-57) > 5 mL in 1 VIAL |
| Product NDC | 45963-612 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Gemcitabine Hydrochloride |
| Non-Proprietary Name | Gemcitabine Hydrochloride |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20150202 |
| End Marketing Date | 20201031 |
| Marketing Category Name | ANDA |
| Application Number | ANDA079160 |
| Manufacturer | Actavis Pharma, Inc. |
| Substance Name | GEMCITABINE HYDROCHLORIDE |
| Strength | 200 |
| Strength Unit | mg/5mL |
| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |