| NDC Code | 68001-282-26 |
|---|
| Package Description | 1 VIAL in 1 CARTON (68001-282-26) > 25 mL in 1 VIAL (68001-282-23) |
|---|
| Product NDC | 68001-282 |
|---|
| 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 | 20110725 |
|---|
| End Marketing Date | 20210801 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA091594 |
|---|
| Manufacturer | BluePoint Laboratories |
|---|
| Substance Name | GEMCITABINE HYDROCHLORIDE |
|---|
| Strength | 38 |
|---|
| Strength Unit | mg/mL |
|---|
| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
|---|