| NDC Code | 0703-5778-01 |
| Package Description | 1 VIAL in 1 CARTON (0703-5778-01) > 25 mL in 1 VIAL |
| Product NDC | 0703-5778 |
| 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 | 20110714 |
| Marketing Category Name | ANDA |
| Application Number | ANDA077983 |
| Manufacturer | Teva Parenteral Medicines, Inc. |
| Substance Name | GEMCITABINE HYDROCHLORIDE |
| Strength | 1 |
| Strength Unit | g/25mL |
| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |