| NDC Code | 70860-204-10 |
| Package Description | 1 VIAL in 1 CARTON (70860-204-10) > 5 mL in 1 VIAL |
| Product NDC | 70860-204 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Gemcitabine |
| Non-Proprietary Name | Gemcitabine Hydrochloride |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20170731 |
| Marketing Category Name | ANDA |
| Application Number | ANDA204520 |
| Manufacturer | Athenex Pharmaceutical Division, LLC. |
| Substance Name | GEMCITABINE HYDROCHLORIDE |
| Strength | 200 |
| Strength Unit | mg/5mL |
| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |