| NDC Code | 16714-930-01 | 
|---|
			| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-930-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 
|---|
			| Product NDC | 16714-930 | 
|---|
			| 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 | 20181101 | 
|---|
			
			| Marketing Category Name | ANDA | 
|---|
			| Application Number | ANDA091365 | 
|---|
			| Manufacturer | NorthStar Rx LLC | 
|---|
			| Substance Name | GEMCITABINE HYDROCHLORIDE | 
|---|
			| Strength | 1 | 
|---|
			| Strength Unit | g/1 | 
|---|
			| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] | 
|---|