| NDC Code | 63323-126-03 |
|---|
| Package Description | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-126-03) / 50 mL in 1 VIAL, SINGLE-DOSE |
|---|
| Product NDC | 63323-126 |
|---|
| 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 | 20110726 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA090799 |
|---|
| Manufacturer | Fresenius Kabi USA, LLC |
|---|
| Substance Name | GEMCITABINE HYDROCHLORIDE |
|---|
| Strength | 2 |
|---|
| Strength Unit | g/50mL |
|---|
| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
|---|