| NDC Code | 
                    0069-3859-10 | 
                
                
                    | Proprietary Name | 
                    Gemcitabine Hydrochloride | 
                
                
                    | Package Description | 
                    50 mL in 1 VIAL (0069-3859-10)  | 
                
                
                    | Product NDC | 
                    0069-3859 | 
                
                
                    | Product Type Name | 
                    HUMAN PRESCRIPTION DRUG | 
                
                
                    | Non Proprietary Name | 
                    Gemcitabine Hydrochloride | 
                
                
                    | Dosage Form Name | 
                    INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 
                
                
                    | Route Name | 
                    INTRAVENOUS | 
                
                
                    | Start Marketing Date | 
                    20110725 | 
                
                
                    | Marketing Category Name | 
                    ANDA | 
                
                
                    | Labeler Name | 
                    Pfizer Laboratories Div Pfizer Inc. | 
                
                
                    | Substance Name | 
                    GEMCITABINE HYDROCHLORIDE | 
                
                
                    | Strength Number | 
                    2 | 
                
                
                    | Strength Unit | 
                    g/50mL | 
                
                
                    | Pharmaceutical Classes | 
                    Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |