| NDC Code | 67457-464-20 |
| Package Description | 1 VIAL in 1 CARTON (67457-464-20) > 5 mL in 1 VIAL |
| Product NDC | 67457-464 |
| 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 | 20140724 |
| Marketing Category Name | ANDA |
| Application Number | ANDA200145 |
| Manufacturer | Mylan Institutional LLC |
| Substance Name | GEMCITABINE HYDROCHLORIDE |
| Strength | 200 |
| Strength Unit | mg/5mL |
| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |