| NDC Code | 16729-118-38 | 
|---|
			| Package Description | 1 VIAL in 1 CARTON (16729-118-38)  > 50 mL in 1 VIAL | 
|---|
			| Product NDC | 16729-118 | 
|---|
			| 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 | 20110831 | 
|---|
			
			| Marketing Category Name | ANDA | 
|---|
			| Application Number | ANDA091594 | 
|---|
			| Manufacturer | Accord Healthcare Inc. | 
|---|
			| Substance Name | GEMCITABINE HYDROCHLORIDE | 
|---|
			| Strength | 2 | 
|---|
			| Strength Unit | g/50mL | 
|---|
			| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] | 
|---|